FDA Adverse Event
Malfunction
Summary report: N
BGR, ANTI-D (MONOCLONAL) (IGG BLEND)
MDR report key: 2024228
·
Received February 25, 2011
Report
- Report Number
- 9610824-2011-00020
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- December 4, 2010
- Report Date
- February 24, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FALSE POSITIVE REACTION WITH SOLIDSCREEN II ANTI-D BLEND. THE CUSTOMER COULD SEND US NEITHER THE SAMPLE NOR THE COMPLAINT PRODUCT. CUSTOMER WAS NOT SURE ABOUT THE USED LOT AND COMPLAINT, THEREFORE, BOTH POSSIBLE LOTS (7019060-01 OR 7945060-01). THE QUALITY CONTROL LABORATORY TESTED THE TWO LOTS WITH DIFFERENT WEEK D POSITIVE AND RH (D) NEGATIVE SAMPLES. ALL REACTIONS WERE CORRECTLY POSITIVE, RESPECTIVELY NEGATIVE. WE DIDN'T OBSERVE ANY FALSE POSITIVE REACTIONS. DUE TO THE REPORTED TEST RESULTS OF CUSTOMER, WE ASSUME THE AFFECTED SAMPLE TO BE WEAK D POSITIVE AND NOT RH (D) NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BGR, ANTI-D (MONOCLONAL) (IGG BLEND) | SOLIDSCREEN II ANTI-D (RH1) BLEND | KSZ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 7019060-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT # 7945060-01, EXP 03/11/2011| (FURTHER LOT OF SUSPECT MEDICAL DEVICE)| TANGO, SERIAL NO. (B)(4)| SOLIDSCREEN II ANTI-D (RH1) BLEND, |