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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (POOLED CELLS); REAGENT RED BLOOD CELLS
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IMMUCOR, INC. CAPTURE-R READY-SCREEN (POOLED CELLS); REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0006436
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/08/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product had already expired prior to the report of the event by the customer, so a device history record review was undertaken by immucor technical support on 27jan2017 which showed that the product had met all specifications prior to market release on (b)(6) 2016.
 
Event or Problem Description
On 26jan2017, a customer site reported via fax an unexpected negative antibody screen when using capture-r ready-screen (pooled cells) on a galileo neo instrument, when tested on (b)(6) 2016.
 
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Brand Name
CAPTURE-R READY-SCREEN (POOLED CELLS)
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key6339253
Report Number1034569-2017-00034
Device Sequence Number19226827
Product Code KSZ
UDI-Device Identifier10888234001959
UDI-Public10888234001959
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
102707
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) 02/17/2017
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 Date12/20/2016
Device Catalogue Number0006436
Device Lot NumberN482
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/26/2017
Initial Report FDA Received Date02/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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