FDA Adverse Event
Malfunction
Summary report: N
VITROS CHEMISTRY PRODUCTS VALP REAGENT
MDR report key: 1060984
·
Received June 11, 2008
Report
- Report Number
- 1319808-2008-00173
- Event Type
- Malfunction
- Date Received
- June 11, 2008
- Date of Event
- May 8, 2008
- Report Date
- May 14, 2008
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Product Code
- LEG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INTO THIS EVENT DETERMINE THAT THE ROOT CAUSE WAS A RESULT OF INCONSISTENT REAGENT PACK HANDLING DURING THE LOADING OF REAGENT. ACCEPTABLE PERFORMANCE WAS OBTAINED FOLLOWING EMPHASIS ON CONSISTENT REAGENT PACK HANDLING. EVALUATION OF INSTRUMENT DATALOGGERS HAS CONCLUDED THAT THE VITROS 5,1 FS SYSTEM WAS OPERATING AS EXPECTED.
Description of Event or Problem · 1
A CUSTOMER OBSERVED NEGATIVELY BIASED QC RESULTS USING VITROS VALP REAGENT ON A VITROS 5,1 FS CHEMISTRY ANALYZER. THERE WAS NO ALLEGATION OF PATIENT HARM AND PATIENT RESULTS WERE NOT REPORTED DURING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITROS CHEMISTRY PRODUCTS VALP REAGENT | IN VITRO DEVICE | LEG | ORTHO-CLINICAL DIAGNOSTICS | NA | 1511-12-8098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |