ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN 806516100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-12 for ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN 806516100 manufactured by Bio-rad Medical Diagnostics Gmbh.

Event Text Entries

[1854170] The customer complained a false negative reaction of a patient sample with anti-human globulin, anti-igg solidscreen ii. The sample was supposed to contain an anti-jk(b). We received the patient sample but not the complained lot of anti-human globulin, anti-igg solidscreen ii. The patient sample was tested with the retention sample on tango in the quality control laboratory and reacted negatively. Furthermore, the sample was tested on gelcard and reacted also negative. A further testing showed a positive reaction of the sample only in the polyethyleneglycol (peg) method. The correct function of the affected lot anti-human globulin, anti-igg solidscreen ii was confirmed by testing different weak antibodies. All positive and negative reactions were correct.
Patient Sequence No: 1, Text Type: D, B5


[9185803] Stn# 125098.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610824-2011-00045
MDR Report Key2070596
Report Source05,06
Date Received2011-04-12
Date of Report2011-04-12
Date of Event2011-03-14
Date Mfgr Received2011-03-16
Date Added to Maude2012-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDR. MARC GORZELLIK
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 SOLIDSCREEN
Generic NameANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN
Product CodeLKJ
Date Received2011-04-12
Catalog Number806516100
Lot Number7016110-05
Device Expiration Date2011-10-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2011-04-12

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