FDA Adverse Event
Malfunction
Summary report: N
REAGENT RED BLOOD CELLLS BIOTESTCELL 3
MDR report key: 2024251
·
Received March 4, 2011
Report
- Report Number
- 9610824-2011-00028
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 4, 2011
- Report Date
- March 4, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- PMA / PMN Number
- 125207-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A KNOWN JK(A) ANTIBODY WITH TWO LOTS OF BIOTESTCELL 3 (LOT 8103011, DATE OF EVENT: (B)(6) 2011 AND LOT 7051011, EXP DATE 02/08/2011, DATE OF EVENT: (B)(6) 2011). CUSTOMER HAS SENT US THE TWO LOTS BIOTESTCELL 3 AND TWO PATIENT SAMPLES. THE TWO PATIENT SAMPLES ARE FROM ONE PATIENT BUT WERE DRAWN AT DIFFERENT TIMES. THE SAMPLES WERE TESTED WITH THE TWO LOTS BIOTESTCELL 3 ON TANGO IN THE QUALITY CONTROL LABORATORY. THE KNOWN JK(A) ANTIBODY OF BOTH SAMPLES REACTED CORRECTLY POSITIVE WITH ALL JK(A) POSITIVE SCREENING CELLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REAGENT RED BLOOD CELLLS BIOTESTCELL 3 | BIOTESTCELL 3 | KSZ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 8103011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXP 02/25/2012| EXP 08/07/2012| SOLIDSCREEN II PLATES: LOT 7028010| AHG ANTI-IGC SSC II: LOT 7035050-01| MLB2: LOT 795111, EXP 12/05/2012 |