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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 0066813
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/09/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
On (b)(6), 2019 immucor technical support used a remote electronic connection method to assess files on echo lumena serial number (b)(4); file showed the camera report optimal and no errors at times of testing.The immucor internal report record number for this report is (b)(4).
 
Event or Problem Description
On (b)(6), 2019 a customer reported an unexpected negative result for an antibody screen on the echo lumena 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 Key9343650
Report Number1034569-2019-00147
Device Sequence Number19389409
Product Code KSZ
UDI-Device Identifier10888234001454
UDI-Public10888234001454
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/19/2019
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 Date12/10/2019
Device Catalogue Number0066813
Device Lot NumberR099
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2019
Initial Report FDA Received Date11/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age33 YR
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