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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 08/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested a returned customer blood sample with retention product of lot number e254 on (b)(6) 2017, which yielded unexpected negative outcomes.The retention product of e254 was also tested by the immucor laboratory on (b)(6) 2017 with another known blood sample containing anti-k, which yielded expected positive outcomes, and so the retention product performed as expected.
 
Event or Problem Description
On (b)(6) 2017, it was determined that a (b)(6) event was reportable as 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 Key7046022
Report Number1034569-2017-00312
Device Sequence Number13476211
Product Code KSZ
UDI-Device Identifier10888234001461
UDI-Public10888234001461
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 11/20/2017
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 Date08/22/2017
Device Catalogue Number0066814
Device Lot NumberE254
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 08/01/2017
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
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