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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 0066213
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/19/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested a returned customer blood sample with retention product of lot number cw333 on (b)(6) 2017, which yielded unexpected negative outcomes.The retention product of cw333 was also tested by the immucor laboratory on (b)(6) 2017 with another known blood sample containing anti-s, 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)(4) event was reportable as an unexpectedly negative antibody screen when tested on a galileo instrument.
 
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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 Key7046274
Report Number1034569-2017-00313
Device Sequence Number13470045
Product Code KSZ
UDI-Device Identifier10888234001171
UDI-Public10888234001171
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
102707/0.0
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 Date11/14/2017
Device Catalogue Number0066213
Device Lot NumberCW333
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 10/25/2017
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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