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

[19658651] The customer complained false negative reactions of a d positive control sample with cell 1 of biotestcell 3. We received the complained lot of biotestcell 3 but not the customer's control sample. Testing of the complained biotestcell 3 lot confirmed weak positive and unclear reactions of different anti-d samples with cell 1 of biotestcell 3 in the tube technique. A review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lot. Due to the confirmed complaint a risk analysis was performed. On the basis of the result of that risk analysis we decided that no market related activities are necessary. A capa has been initiated to intensify the efforts to find the root cause for this complaint.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610824-2011-00093
MDR Report Key2219033
Report Source05
Date Received2011-07-21
Date of Report2011-07-21
Date of Event2011-06-28
Date Mfgr Received2011-06-28
Date Added to Maude2012-05-31
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 StreetINDUSTRIESTRASSE 1
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 Mfg2011-07-08
Catalog Number816085100
Lot Number8123011
Device Expiration Date2011-07-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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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