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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 immucor laboratory tested retention product on (b)(6) 2017, which performed as expected.The immucor laboratory also tested a returned blood sample from the customer site on (b)(6) 2017 against retention product, which yielded an expected positive outcome.
 
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 Key7046828
Report Number1034569-2017-00314
Device Sequence Number16160016
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 Age54 YR
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