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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-B (MURINE MONOCLONAL) SERIES 3; BLOOD GROUPING REAGENT
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IMMUCOR, INC. ANTI-B (MURINE MONOCLONAL) SERIES 3; BLOOD GROUPING REAGENT Back to Search Results
Catalog Number 0006406
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/07/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method to assess the test well images on the testing instrument on (b)(6) 2016 which was visually positive.The immucor laboratory tested retention product (b)(6) 2016 and (b)(6) 2016, which performed as expected.The immucor laboratory also tested a returned blood sample on (b)(6) 2016 which yielded an ntd outcome.
 
Event or Problem Description
On (b)(6) 2016, a customer reported an unexpected positive result when using anti-b (murine monoclonal) series 3 on a galileo instrument.
 
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Brand Name
ANTI-B (MURINE MONOCLONAL) SERIES 3
Common Device Name
BLOOD GROUPING REAGENT
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key6221498
Report Number1034569-2017-00009
Device Sequence Number16498472
Product Code KSZ
UDI-Device Identifier10888234000532
UDI-Public10888234000532
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
102692/1009
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Medical Technologist
Type of Report Initial
Report Date (Section B) 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Medical Technologist
Device Expiration Date06/14/2018
Device Catalogue Number0006406
Device Lot Number203660
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2016
Initial Report FDA Received Date01/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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