FDA Adverse Event
Malfunction
Summary report: N
REAGENT RED BLOOD CELLS BIOTESTCELL 1&2
MDR report key: 2944871
·
Received February 6, 2013
Report
- Report Number
- 9610824-2013-00005
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- December 7, 2012
- Report Date
- February 6, 2013
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HE MISSED AN ANTI-FY(A) OF A PROFICIENCY SURVEY SAMPLE WHEN TESTING WITH BIOTESTCELL 1 AND 2. THE CUSTOMER HAS NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PROFICIENCY SURVEY SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME THE CUSTOMER FILED THIS COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT HAD ALREADY BEEN EXPIRED. THEREFORE A TESTING OF THE RETAINED BIOTESTCELL 1 AND 2 SAMPLE WAS NOT POSSIBLE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51129 | REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 | BIOTESTCELL 1&2 | KSZ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 8243011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MLB2, LOT 8209060, EXP. 02/16/2014 |