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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (I AND II); REAGENT RED BLOOD CELLS
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IMMUCOR, INC. CAPTURE-R READY-SCREEN (I AND II); REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0006440
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The implicated product had a dhr review on (b)(6) 2017 for information regarding leb antigen reactivity, and it was determined that the presence of leb antigen was confirmed in bulk testing.
 
Event or Problem Description
On (b)(6) 2017, an immucor employee visiting a customer site, reported on behalf of the customer an unexpectedly negative antibody screen when tested on a galileo instrument.
 
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Brand Name
CAPTURE-R READY-SCREEN (I AND II)
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key7046850
Report Number1034569-2017-00315
Device Sequence Number13755899
Product Code KSZ
UDI-Device Identifier10888234000648
UDI-Public10888234000648
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
102707/0.0
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/20/2017
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 Date10/31/2017
Device Catalogue Number0006440
Device Lot NumberX473
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/26/2017
Initial Report FDA Received Date11/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age24 YR
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