2026 data FDA MAUDE openFDA FDA Class II

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §862.1215 (Clinical Chemistry panel).

FDA MAUDE casebook

openFDA event book Nad Reduction/Nadh Oxidation LIGHT-BOOK · MAUDE

#569 of 1000 · 1,513 reports · 2007–2026

  • BOOK 1,513 reports
  • RANK #569 of 1000
  • DEATH 0 death-typed
  • INJ 2 injury-typed
  • MALF 1,510 malfunction
  • SPAN 2007–2026
  • PEAK 2018: 1,434
  • PHOTO Continuous Glucose Mo…

Nearest event-volume peer: Continuous Glucose Monitor, Implanted, Adjunctive Use (1 report gap)

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes sits #569 of 1000 among tracked device types with 1,513 MAUDE reports spanning 2007–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Nad Reduction/Nadh Oxidation carries 99.8% MALFUNCTION-coded reports, 35.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.1% corpus 30.3% · below corpus mean (-30.2 pp)
  • MALF 99.8% corpus 64.8% · above corpus mean (+35.0 pp)

Lead product-problem code Unable to Obtain Readings is 84% of coded problems · Lead manufacturer ABBOTT MANUFACTURING INC accounts for 96% of manufacturer-tagged reports · Top event location I is 95% of location-tagged rows .

Nad Reduction/Nadh Oxidation in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes carries 1,513 MAUDE reports, ranked #569 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,510 (99.8%)
Injury 2 (0.1%)
1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,509 (99.7%)
Congenital Anomaly 2 (0.1%)
Other 2 (0.1%)

Top Product Problems

Unable to Obtain Readings 1,358
Low Test Results 257
High Test Results 2
Fluid/Blood Leak 1
Human Factors Issue 1
Incorrect Or Inadequate Test Results 1
Patient-Device Incompatibility 1

Yearly Trend

07
2007: 64
10
2010: 1
11
2011: 3
17
2017: 2
18
2018: 1,434
19
2019: 4
22
2022: 1
24
2024: 1
25
2025: 2
26
2026: 1

Reports rose to 2 in 2025, up from an average of 1 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Event Locations

I 1,440 (95.2%)
72 (4.8%)
LABORATORY 1 (0.1%)

Compare ABBOTT MANUFACTURING INC vs ABBOTT MANUFACTURING, INC. →

Nationwide devices with a comparable report-volume footprint

Nad Reduction/Nadh Oxidation carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,513 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Nad Reduction/Nadh Oxidation are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Nad Reduction/Nadh Oxidation; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.