FDA Adverse Event
Malfunction
Summary report: N
ANTI-HUMAN GLOBULIN ANTI-IGG
MDR report key: 2254838
·
Received August 23, 2011
Report
- Report Number
- 9610824-2011-00115
- Event Type
- Malfunction
- Date Received
- August 23, 2011
- Date of Event
- June 22, 2011
- Report Date
- August 23, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- LKJ
- PMA / PMN Number
- 125215
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADD'L EVENT DATE: (B)(6) 2011.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINED THAT THEY MISSED TWO ANTIBODIES (ANTI-E AND ANTI-CW) WITH ANTI-IGG ART#: (B)(4), LOT# 7039091-04. CUSTOMER HAS SENT US NEITHER THE PT SAMPLE NOR THE ALLEGEDLY DEFECTIVE SAMPLE ANTI-IGG. THEREFORE, THE RETENTION SAMPLE OF ANTI-IGG WAS TESTED IN OUR QUALITY CONTROL LAB, USING DIFFERENT WEAK ANTIBODIES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING OF OUR QUALITY CONTROL LAB CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF ANTI-IGG. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANTI-HUMAN GLOBULIN ANTI-IGG | AHG ANTI-IGG | LKJ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 7039091-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MLB2: LOT 7951111, EXP: 12/05/2011| BIOTESTCELL 3, LOT 8123021, EXP: 07/26/2011 |