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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID EXTEND I; REAGENT RED BLOOD CELLS
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IMMUCOR, INC. CAPTURE-R READY-ID EXTEND I; REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0006455
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/14/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method to assess the instrument test well images in question on (b)(6) 2017, which visually appeared negative.The immucor laboratory tested retention product on 23jun2017, which performed as expected.
 
Event or Problem Description
On (b)(6) 2017, a customer site reported an unexpected negative antibody identification when using capture-r ready-id extend i when used on two (2) galileo echo instruments.
 
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Brand Name
CAPTURE-R READY-ID EXTEND I
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key6693443
Report Number1034569-2017-00130
Device Sequence Number19074813
Product Code KSZ
UDI-Device Identifier10888234000679
UDI-Public10888234000679
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
102707/5030
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) 07/07/2017
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 Date06/27/2017
Device Catalogue Number0006455
Device Lot NumberDP094
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 06/14/2017
Initial Report FDA Received Date07/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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