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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (I AND II); REAGENT RED BLOOD CELLS
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IMMUCOR, INC. CAPTURE-R READY-SCREEN (I AND II); REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0006440
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/04/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 15nov2017 to assess the instrument test well images in question, which appeared to have slight red blood cell adherence in the background.
 
Event or Problem Description
On 15nov2017, a customer site reported an unexpectedly negative antibody screen when tested on a galileo neo instrument, when tested on (b)(6) 2017.
 
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Brand Name
CAPTURE-R READY-SCREEN (I AND II)
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key7105444
Report Number1034569-2017-00332
Device Sequence Number11071520
Product Code KSZ
UDI-Device Identifier10888234000648
UDI-Public10888234000648
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) 12/11/2017
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 Date12/27/2017
Device Catalogue Number0006440
Device Lot NumberX475
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 11/15/2017
Initial Report FDA Received Date12/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age67 YR
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