FDA Adverse Event
Malfunction
Summary report: N
ELECSYS HE4
MDR report key: 24628416
·
Received March 18, 2026
Report
- Report Number
- 1823260-2026-00983
- Event Type
- Malfunction
- Date Received
- March 18, 2026
- Date of Event
- February 25, 2026
- Report Date
- March 18, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- OIU
- UDI-DI
- 04015630940219
- PMA / PMN Number
- K112624
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HE4 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 15.0 PMOL/L WITH FLAG. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 73.9 PMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688448 | ELECSYS HE4 | HUMAN EPIDIDYMIS PROTEIN 4 (HE4) IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY | OIU | ROCHE DIAGNOSTICS | 84981601 | 04015630940219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |