FDA Adverse Event
Malfunction
Summary report: N
BLOOD GROUPING REAGENT ANTI-S (MNS3)
MDR report key: 2024207
·
Received February 1, 2011
Report
- Report Number
- 9610824-2011-00025
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 31, 2011
- Report Date
- March 1, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- LKJ
- PMA / PMN Number
- 125216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS REPORT CONCERNS TWO BATCHES OF SERACLONE ANTI-S, ART. NO. (B)(4). IN ADDITION TO THE LOT NUMBER, THE LOT 7025110-01 (EXP DATE 06/12/2012) IS AFFECTED AS WELL. THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF S POSITIVE CELLS FROM THEIR CELL PANEL OF A COMPETITOR. THE PANEL CELLS ARE USED AS CONTROL CELLS. THE CUSTOMER HAS SENT US THE TWO COMPLAINED LOTS BUT NOT THE PANEL CELLS. THE TWO COMPLAINT SAMPLES OF CUSTOMER WERE TESTED WITH DIFFERENT S POSITIVE RED CELLS AND REACTED CORRECTLY POSITIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOOD GROUPING REAGENT ANTI-S (MNS3) | SERACLONE ANTI-S (MNS3) | LKJ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 7002130-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SERACLONE ANTI-S: LOT# 7025110-01, EXP 06/12/2012| IMMUCOR PANOCELL 20: LOT# 50613, EXP 02/18/2011 |