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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 0066803
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on 27jul2017 which performed as expected.Immucor technical support used a remote electronic connection method to assess the instrument test wells in question on (b)(6)2017, which appeared as visually positive.
 
Event or Problem Description
On (b)(6)2017, a canadian customer site reported an unexpected negative antibody screen when using capture-r ready-screen (3) with 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 Key6794581
Report Number1034569-2017-00200
Device Sequence Number1540989
Product Code KSZ
UDI-Device Identifier10888234001416
UDI-Public10888234001416
Combination Product (Y/N)N
Initial Reporter CountryCA
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) 08/15/2017
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 Date10/17/2017
Device Catalogue Number0066803
Device Lot NumberR904
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 07/26/2017
Initial Report FDA Received Date08/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age80 YR
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