FDA Adverse Event
Malfunction
Summary report: N
CALCIUM GEN. 2
MDR report key: 19763731
·
Received July 17, 2024
Report
- Report Number
- 1823260-2024-02062
- Event Type
- Malfunction
- Date Received
- July 17, 2024
- Date of Event
- May 30, 2024
- Report Date
- August 29, 2024
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CHW
- UDI-DI
- 04015630924936
- PMA / PMN Number
- K113521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE C702 MODULE SERIAL NUMBER WAS (B)(6).
Additional Manufacturer Narrative · 0
QC WAS ACCEPTABLE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative · 0
THE CUSTOMER REPORTED THREE NEW QUESTIONABLE CALCIUM GEN. 2 (CA2) RESULTS. THE CUSTOMER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: ON (B)(6) 2024: SAMPLE ID (B)(6) THE INITIAL RESULT WAS 2.28 MMOL/L. THE REPEAT RESULT WAS 3.72 MMOL/L.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 13 PATIENT SAMPLES TESTED FOR CALCIUM GEN. 2 (CA2) ON A COBAS 8000 C 702 MODULE BETWEEN (B)(6) 2024. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362912 | CALCIUM GEN. 2 | TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM | CHW | ROCHE DIAGNOSTICS | ASKU | 04015630924936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |