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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-A (MURINE MONOCLONAL) SERIES 1; BLOOD GROUPING REAGENT
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IMMUCOR, INC. ANTI-A (MURINE MONOCLONAL) SERIES 1; BLOOD GROUPING REAGENT Back to Search Results
Catalog Number 0006400
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/20/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method to assess the test well image in question on the testing instrument and determined that the test well image was visually negative.
 
Event or Problem Description
On (b)(6) 2017, it was determined that a customer event of unexpected negative well result when using anti-a (murine monoclonal) series 1 on a galileo instrument was to be reported.Customer testing of the blood sample in question was on (b)(6) 2017.
 
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Brand Name
ANTI-A (MURINE MONOCLONAL) SERIES 1
Common Device Name
BLOOD GROUPING REAGENT
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key6445775
Report Number1034569-2017-00065
Device Sequence Number1378450
Product Code KSZ
UDI-Device Identifier10888234000525
UDI-Public10888234000525
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
102691/0.0
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) 03/30/2017
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 Date03/31/2018
Device Catalogue Number0006400
Device Lot Number101786
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2017
Initial Report FDA Received Date03/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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