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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (3); REAGENT RED BLOOD CELLS
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IMMUCOR, INC. CAPTURE-R READY-SCREEN (3); REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0066814
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/12/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested one (1) returned customer blood sample ((b)(6)) with retention product of lot number e265 on (b)(6) 2017, which yielded expected positive outcomes.The retention product of e265 was also tested by the immucor laboratory on (b)(6) 2017 with another known blood sample containing anti-d, which yielded expected positive outcomes, and so the retention product performed as expected.
 
Event or Problem Description
On (b)(6) 2017, a european (b)(6) customer site reported an unexpectedly negative antibody screen when tested on a galileo echo instrument.
 
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Brand Name
CAPTURE-R READY-SCREEN (3)
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key7004287
Report Number1034569-2017-00300
Device Sequence Number16544131
Product Code KSZ
UDI-Device Identifier10888234001461
UDI-Public10888234001461
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
102707/5045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Medical Technologist
Type of Report Initial
Report Date (Section B) 11/06/2017
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 Date12/15/2017
Device Catalogue Number0066814
Device Lot NumberE265
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2017
Initial Report FDA Received Date11/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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