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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-ID EXTEND I; AUTOMATED BLOOD BANK SYSTEM
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IMMUCOR, INC. CAPTURE-R READY-ID EXTEND I; AUTOMATED BLOOD BANK SYSTEM Back to Search Results
Catalog Number 0006454
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor was not able to review actual test results or instrument data (not provided).No sample or product was returned to immucor for evaluation.The immucor internal report record number for this report is (b)(4).
 
Event or Problem Description
On (b)(6) 2018 a customer reported that they received unexpected negative reactions with capture-r ready-id extend i on an echo v2.0 instrument.
 
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Brand Name
CAPTURE-R READY-ID EXTEND I
Common Device Name
AUTOMATED BLOOD BANK SYSTEM
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key8245589
Report Number1034569-2019-00014
Device Sequence Number2141857
Product Code KSZ
UDI-Device Identifier10888234000662
UDI-Public10888234000662
Combination Product (Y/N)N
Initial Reporter StateMI
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/14/2019
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 Date01/08/2019
Device Catalogue Number0006454
Device Lot NumberDP104
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2018
Initial Report FDA Received Date01/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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