FDA Adverse Event
Malfunction
Summary report: N
BLOOD GROUPING REAGENT ANTI-A (ABO1)
MDR report key: 1983116
·
Received January 17, 2011
Report
- Report Number
- 9610824-2011-00004
- Event Type
- Malfunction
- Date Received
- January 17, 2011
- Date of Event
- December 7, 2010
- Report Date
- January 18, 2011
- Manufacturer
- BIO-RAD MED DIAGNOSTICS GMBH
- Product Code
- KSF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT TWO SAMPLES REACTED FALSELY POSITIVE WITH SERACLONE ANTI-A ART NO. 801325100, LOT 7003130-03. THE CUSTOMER HAS SENT US THE TWO PT SAMPLES BUT NOT THE COMPLAINED REAGENT. THEREFORE, THE RETENTION SAMPLE OF QUALITY CONTROL LABORATORY WAS TESTED WITH THE TWO PT SAMPLES IN DIFFERENT METHODS. THE TWO SAMPLES REACTED CORRECTLY AND UNAMBIGUOUSLY NEGATIVE. ALTHOUGH THE TWO SAMPLES WERE SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR BLOOD GROUP TYPING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOOD GROUPING REAGENT ANTI-A (ABO1) | SERACLONE ANTI-A | KSF | BIO-RAD MED DIAGNOSTICS GMBH | 7003130-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |