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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 Known Impact Or Consequence To Patient (2692)
Date of Event 02/02/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 03feb2017 to assess the instrument test well images in question, and determined that they appeared consistent with the instrument result outputs.The immucor laboratory tested retention product on 08feb2017 which performed as expected.The immucor laboratory also tested a returned blood sample on 08feb2017 that had been sent from the customer site and determined that this blood sample performed as expected.
 
Event or Problem Description
On 03feb2017, a customer reported an unexpected positive result when using anti-b (murine monoclonal) series 3 on a galileo instrument, when tested on (b)(6) 2017.
 
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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 Key6357280
Report Number1034569-2017-00039
Device Sequence Number11006681
Product Code KSZ
UDI-Device Identifier10888234000532
UDI-Public10888234000532
Combination Product (Y/N)N
Initial Reporter StateMO
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) 02/24/2017
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 Date02/17/2018
Device Catalogue Number0006406
Device Lot Number203640
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2017
Initial Report FDA Received Date02/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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