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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 0066804
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/12/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor tested retention capture-r ready-screen 3 lot number e344 (expiry august 20, 2019) and product performed as expected.No product defect was identified.On june 13, 2019 immucor technical support used a remote electronic connection method to assess files on the customer's gallieo echo v2.0 instrument; no errors were found in the error log.(b)(4).
 
Event or Problem Description
On (b)(6) 2019 a customer reported an unexpected negative result with capture-r ready-screen 3 on the echo v2.0 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 Key8769369
Report Number1034569-2019-00113
Device Sequence Number19413455
Product Code KSZ
UDI-Device Identifier10888234001423
UDI-Public10888234001423
Combination Product (Y/N)N
Initial Reporter CountryIT
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) 07/08/2019
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 Date08/20/2019
Device Catalogue Number0066804
Device Lot NumberE344
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2019
Initial Report FDA Received Date07/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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