FDA Adverse Event
Malfunction
Summary report: N
BLOOD GROUPING REAGENT ANTI-A (ABO1)
MDR report key: 2680378
·
Received December 16, 2010
Report
- Report Number
- 9610824-2010-00028
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- November 22, 2010
- Report Date
- December 15, 2010
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED WEAKLY FALSE POSITIVE REACTIONS OF A B POSITIVE UNIT OF BLOOD WITH BLOOD GROUPING REAGENT SERACLONE ANTI-A ART. (B)(4), LOT 7003130-01. THE CUSTOMER HAS SENT US SEGMENTS FROM THE UNIT OF BLOOD WHICH HAD REACTED FALSE POSITIVE AND A VIAL OF THE COMPLAINED LOT OF REAGENT. THE COMPLAINED VIAL WAS TESTED WITH A SEGMENT OF THE B POSITIVE UNIT OF BLOOD IN THE IMMEDIATE SPIN METHOD. THE WEAKLY POSITIVE REACTION OF THE CUSTOMER WAS CONFIRMED. THE WEAKLY POSITIVE REACTION WAS ALSO CONFIRMED BY THE TESTING OF REAGENTS OF COMPETITORS. SEGMENTS OF THE B POSITIVE UNIT OF BLOOD ARE SENT FOR MOLECULAR TYPING OF 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 | 7003130-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |