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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 0066214
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/08/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(6) 2017 to assess test well images in question.Two (2) of the three (3) wells were visually negative, and one (1) of the three (3) wells was visually weak positive.The immucor laboratory tested retention product on (b)(6) 2017, which performed as expected.
 
Event or Problem Description
On 11jul2017, a customer site reported an unexpected negative antibody identification when using capture-r ready-id when used on a galileo neo instrument, when tested on (b)(6) 2017.
 
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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 Key6751731
Report Number1034569-2017-00159
Device Sequence Number13685988
Product Code KSZ
UDI-Device Identifier10888234001188
UDI-Public10888234001188
Combination Product (Y/N)N
Initial Reporter StatePA
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 Medical Technologist
Type of Report Initial
Report Date (Section B) 07/28/2017
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 Number0066214
Device Lot NumberID341
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 07/11/2017
Initial Report FDA Received Date07/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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