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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D MONOCLONAL BLEND SERIES 4; REAGENT RED BLOOD CELLS
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IMMUCOR, INC. ANTI-D MONOCLONAL BLEND SERIES 4; REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 006412
Medical Device Problem Code False Positive Result (1227)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
This report summarizes 1 malfunction events.A review of the events indicated that one (1) pooled test that included six (6) donor samples produced an rh mistype with a result of d+ versus a d- known phenotype using the anti-d series 4 reagent on an automated blood bank system.Subsequent testing of reagent retention lots, reviews of design history records and reagent antigen validation testing of the initial bulk product used for commercial vialing showed acceptable results.Through post event tests and investigations, no specific causes were determined for the malfunctions.
 
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Brand Name
ANTI-D MONOCLONAL BLEND SERIES 4
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross, ga
MDR Report Key10347346
Report Number1034569-2020-00052
Device Sequence Number2259520
Product Code QHT
UDI-Device Identifier10888234000556
UDI-Public10888234000556
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
103523/0.0
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number006412
Device Lot Number504876
Was Device Available for Evaluation? Yes
Type of Report(Section G)Periodic
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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