FDA Adverse Event
Malfunction
Summary report: N
REAGENT RED BLOOD CELLS BIOTESTCELL 3
MDR report key: 2209622
·
Received August 3, 2011
Report
- Report Number
- 9610824-2011-00104
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 5, 2011
- Report Date
- August 4, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- LKJ
- PMA / PMN Number
- 125207-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER COMPLAINED (B)(6) REACTIONS WITH CELL 2 OF BIOTESTCELL 3. WE RECEIVED NEITHER THE AFFECTED SAMPLES NOR THE COMPLAINED LOT OF BIOTESTCELL 3. THEREFORE THE RETENTION SAMPLE WAS TESTED WITH (B)(6) CONTROL AND DIFFERENT PLASMA SAMPLES. ALL (B)(6) REACTIONS WERE CORRECT. WE DIDN'T OBSERVE ANY (B)(6) REACTIONS. SUMMARY: THE TESTING QUALITY CONTROL LAB HAD CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF BIOTESTCELL 3. THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REAGENT RED BLOOD CELLS BIOTESTCELL 3 | BIOTESTCELL 3 | LKJ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 8123021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ORTHO PANEL, LOT VRA157, EXP. 07/26/2011| ORTHO ENHANCEMENT, LOT AEF333A, EXP. 01/19/2012| BIO-RAD ANTI-IGG, LOT 8102140-02, EXP. 07/06/2012| BIO-RAD MLB 2, LOT 8046070, EXP. 11/07/2012 |