ANTI-HUMAN GLOBULIN ANTI-IGG 804175100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-23 for ANTI-HUMAN GLOBULIN ANTI-IGG 804175100 manufactured by Bio-rad Medical Diagnostics Gmbh.

Event Text Entries

[2158370] 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.
Patient Sequence No: 1, Text Type: D, B5


[9474954] Add'l event date: (b)(6) 2011.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610824-2011-00115
MDR Report Key2254838
Report Source05
Date Received2011-08-23
Date of Report2011-08-23
Date of Event2011-06-22
Date Mfgr Received2011-07-25
Date Added to Maude2012-05-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDR. MARC GORZELLIK, HEAD
Manufacturer StreetINDUSTRIESTRASSE 1
Manufacturer CityDREIEICH 63303
Manufacturer CountryGM
Manufacturer Postal63303
Manufacturer Phone103801528
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANTI-HUMAN GLOBULIN ANTI-IGG
Generic NameAHG ANTI-IGG
Product CodeLKJ
Date Received2011-08-23
Catalog Number804175100
Lot Number7039091-04
Device Expiration Date2013-09-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIO-RAD MEDICAL DIAGNOSTICS GMBH
Manufacturer AddressINDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303


Patients

Patient NumberTreatmentOutcomeDate
10 2011-08-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.