FDA Adverse Event
Malfunction
Summary report: N
BLOOD GROUPING REAGENT ANTI-A (ABO1)
MDR report key: 2024205
·
Received February 1, 2011
Report
- Report Number
- 9610824-2011-00023
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 17, 2011
- Report Date
- March 1, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- PMA / PMN Number
- 125219
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED WEAKLY FALSE POSITIVE REACTIONS OF A SAMPLE WITH SERACLONE ANTI-A ART. NO. 801325100, LOT 7018010-04. THE AFFECTED SAMPLE WAS TESTED AT THE (B)(6) BLOOD SERVICES AS BLOODGROUP B. THE CUSTOMER HAS SENT US THE PATIENT SAMPLE BUT NOT A VIAL OF THE COMPLAINED LOT OF REAGENT. THEREFORE, PATIENT SAMPLE WAS TESTED WITH THE RETENTION SAMPLE IN THE IMMEDIATE SPIN METHOD. THE REACTION WAS CLEARLY NEGATIVE. EVEN DURING A LONGER INCUBATION AT 4 DEGREES C WHICH IS NOT ACCORDING TO THE INFORMATION OF THE INSTRUCTION FOR USE, A CLEAR NEGATIVE REACTION WAS OBSERVED. DESPITE OUR TEST RESULTS THE PATIENT SAMPLE WAS SENT FOR MOLECULAR TYPING OF THE ABO BLOOD GROUP TO AN EXTERNAL LABORATORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOOD GROUPING REAGENT ANTI-A (ABO1) | SERACLONE ANTI-A | KSZ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 7018010-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMMUCOR ANTI-A: LOT# 104013-1, EXP 05/16/2012| ORTHO ANTI-A: LOT# BAA584-A, EXP 02/02/2012| SERACLONE ANTI-B (801350100): LOT# 7027120-07| EXP 06/27/2012 |