REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100

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 2011-07-21 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.

Event Text Entries

[20792623] The customer complained that pt samples yielded a false (b)(6) reaction with biotestcell 3 in the tube technique. We received the affected sample and the allegedly defective lot of biotestcell 3. The sample was retested with complaint sample and retention sample of biotestcell 3 in tube technique in our quality control lab. The pt sample displayed a (b)(6) reaction in the indirect anti-human globulin test (iat). The sample was also tested in the gel method and reacted (b)(6). Furthermore the sample was tested with the complaint sample of biotestcell 3 in the enzyme method and reacted (b)(6) with the affected (b)(6) screening cell. The correct function of the affected lot biotestcell 3 was confirmed by testing two different anti-e from an interlaboratory comparison testing. Both antibodies reacted correctly (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610824-2011-00092
MDR Report Key2219034
Report Source05
Date Received2011-07-21
Date of Report2011-07-21
Date of Event2011-06-27
Date Mfgr Received2011-06-27
Date Added to Maude2012-04-24
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 MARK GORZELLIK, HEAD
Manufacturer StreetLANDSTEINERSTR. 5
Manufacturer CityDREIEICH 63303
Manufacturer CountryGM
Manufacturer Postal63303
Manufacturer Phone103801528
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREAGENT RED BLOOD CELLS BIOTESTCELL 3
Generic NameBIOTESTCELL 3
Product CodeLKJ
Date Received2011-07-21
Returned To Mfg2011-07-12
Catalog Number816085100
Lot Number8119011
Device Expiration Date2011-06-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIO-RAD MEDICAL DIAGNOSTICS GMBH
Manufacturer AddressINDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303


Patients

Patient NumberTreatmentOutcomeDate
10 2011-07-21

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