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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 11/25/2019
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 was acceptable and nothing significant was seen in event log.The immucor internal report record number for this event is (b)(4).
 
Event or Problem Description
On (b)(6) 2019 a customer reported unexpected negative antibody screening results with capture-r ready screen 3 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 Key9491774
Report Number1034569-2019-00150
Device Sequence Number209177
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) 12/18/2019
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 11/25/2019
Initial Report FDA Received Date12/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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