FDA Adverse Event
Malfunction
Summary report: N
ERYTYPE S AB0+D
MDR report key: 2011946
·
Received February 8, 2011
Report
- Report Number
- 9610824-2011-00013
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 7, 2011
- Report Date
- February 4, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS WITH ANTI-B AND ONLY WEAK POSITIVE REACTIONS WITH ANTI-AB ON ERYTYPE AB0+D. THE CUSTOMER HAS SENT US THE COMPLAINED LOT OF ERYTYPE AB0+D. THE SAMPLE WAS TESTED MANUALLY WITH DIFFERENT FRESH RED CELLS OF VARIOUS ABO BLOOD GROUPS. ALL POSITIVE REACTIONS WITH THE ANTI-B AND THE ANTI-AB REAGENTS WERE STRONGLY AND CORRECTLY POSITIVE. WE DIDN'T OBSERVE ANY FALSE NEGATIVE RESULTS. THEREFORE, WE CANNOT CONFIRM THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ERYTYPE S AB0+D | ERYTYPE S AB0+D | KSZ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 1009120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |