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 2011-08-03 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.

Event Text Entries

[2201893] The customer complained false negative reactions of a d positive control sample with cell 1 of biotestcell 3. Customer had sent neither the complained lot of biotestcell 3 nor the control.
Patient Sequence No: 1, Text Type: D, B5


[9219597] Summary: the 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 the 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 the complaint.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610824-2011-00097
MDR Report Key2209595
Report Source05
Date Received2011-08-03
Date of Report2011-08-04
Date of Event2011-07-06
Date Mfgr Received2011-07-06
Date Added to Maude2012-05-11
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 NameREAGENT RED BLOOD CELLS BIOTESTCELL 3
Generic NameBIOTESTCELL 3
Product CodeLKJ
Date Received2011-08-03
Catalog Number816085100
Lot Number8123011
Device Expiration Date2011-07-26
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 2011-08-03

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