FDA Adverse Event
Malfunction
Summary report: N
ELECSYS VITAMIN D TOTAL III
MDR report key: 24627855
·
Received March 18, 2026
Report
- Report Number
- 1823260-2026-00975
- Event Type
- Malfunction
- Date Received
- March 18, 2026
- Date of Event
- February 17, 2026
- Report Date
- April 22, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- MRG
- UDI-DI
- 07613336172650
- PMA / PMN Number
- K210901
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative · 0
THE ANALYZER'S SERIAL NUMBER IS: (B)(6). THE LEVEL 2 QC WAS ACCEPTABLE. THE CUSTOMER DID NOT TEST LEVEL 1 QC. SAMPLE CLOT ALARMS WERE DETECTED ON THE DATE OF THE EVENT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D, TOTAL III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 99.1 NG/ML. ON (B)(6) 2026, THE REPEATED RESULT WAS 32.9 NG/ML (REPORTED AS 33 NG/ML). THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299277 | ELECSYS VITAMIN D TOTAL III | VITAMIN D TEST SYSTEM | MRG | ROCHE DIAGNOSTICS | 88165901 | 07613336172650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |