FDA Adverse Event
Malfunction
Summary report: N
LACTATE DEHYDROGENASE
MDR report key: 20261177
·
Received September 19, 2024
Report
- Report Number
- 1823260-2024-02714
- Event Type
- Malfunction
- Date Received
- September 19, 2024
- Date of Event
- August 23, 2024
- Report Date
- November 15, 2024
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CFJ
- UDI-DI
- 04015630916276
- PMA / PMN Number
- K964457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE COBAS 6000 C501 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE ISSUE WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. AN EFFECT FROM THE PATIENT'S BETA-THALASSEMIA COULD NOT BE RULED OUT. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE RESULTS FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 629 U/L. THE REPEAT RESULTS WERE 884 U/L AND 427 U/L. THE INITIAL RESULT WAS BELIEVED TO BE CORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2295381 | LACTATE DEHYDROGENASE | LACTATE DEHYDROGENASE ASSAY USING NAD/NADH | CFJ | ROCHE DIAGNOSTICS | 04015630916276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |