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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID; REAGENT RED BLOOD CELLS
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IMMUCOR, INC. CAPTURE-R READY-ID; REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0066204
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/15/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 16jul2018 to assess the instrument test well images in question, which appeared visually negative.The immucor laboratory had previously tested retention product on 12jul2018 which was performing as expected.(b)(4).
 
Event or Problem Description
On 16jul2018, a customer site reported an unexpectedly negative antibody identification when using capture-r ready-id when used on a galileo echo instrument, when tested on (b)(6) 2018.
 
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Brand Name
CAPTURE-R READY-ID
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key7731527
Report Number1034569-2018-00178
Device Sequence Number1588373
Product Code KSZ
UDI-Device Identifier10888234001140
UDI-Public10888234001140
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
102707/0.0
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/30/2018
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 No Information
Device Expiration Date07/24/2018
Device Catalogue Number0066204
Device Lot NumberID360
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/16/2018
Initial Report FDA Received Date07/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age56 YR
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