FDA Adverse Event
Malfunction
Summary report: N
BLOOD GROUPING REAGENT ANTI-A (ABO1)
MDR report key: 2455928
·
Received January 24, 2011
Report
- Report Number
- 9610824-2011-00207
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- November 22, 2010
- Report Date
- February 23, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- PMA / PMN Number
- 125219
- 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. ¿NO. (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. DUE TO TECHNICAL PROBLEMS THE MOLECULAR TYPING OF ABO BLOOD GROUP WAS NOT POSSIBLE.
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 |