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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D MONOCLONAL BLEND; REAGENT RED BLOOD CELLS
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IMMUCOR, INC. ANTI-D MONOCLONAL BLEND; REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0420503
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 malfunction events.A review of the events indicated that one (1) patient test produced an rh mistype with a false positive using manual tube weak-d testing and an anti-d monoclonal 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
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross, ga
MDR Report Key10347350
Report Number1034569-2020-00053
Device Sequence Number2259516
Product Code QHT
UDI-Device Identifier10888234001768
UDI-Public10888234001768
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
103629/0
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 Number0420503
Device Lot Number506280
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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