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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 08/30/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The implicated product was assessed with a dhr review which was performed on 24oct2017, which indicated that the product performed as expected at the time of product release.The immucor laboratory tested retention product on 20oct2017 which performed as expected.
 
Event or Problem Description
On (b)(6) 2017, a customer site, reported forty-three (43) historically unexpectedly negative antibody screens when tested on a galileo instrument, when tested between (b)(6) 2017.
 
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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 Key7025327
Report Number1034569-2017-00305
Device Sequence Number944871
Product Code KSZ
UDI-Device Identifier10888234000648
UDI-Public10888234000648
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
102707/0.0
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) 11/13/2017
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 10/19/2017
Initial Report FDA Received Date11/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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