BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 9884212 · Received March 26, 2020

    Report

    Report Number
    3002809144-2020-00218
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 14, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D. SUSPECT MEDICAL DEVICE, 2. PRODUCT CODE FROM MZO TO QHM. A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LOT 09221BE00, AND NO TRENDS WERE IDENTIFIED FOR THIS ASSAY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. SPECIFICITY TESTING WAS PERFORMED WITH A RETAINED KIT OF LOT 09221BE00 AND 220 PANEL MEMBERS OF HUMAN NEGATIVE POPULATION PANEL TIER1. OVERALL, THE SPECIFICITY PANEL MET SPECIFICATIONS AND NO FALSE REACTIVE RESULTS WERE OBTAINED. FURTHER ADDITIONAL REPLICATES OF THE NEGATIVE CONTROL WERE TESTED WHICH ALL MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY S ANTI-HCV REAGENT, LOT 09221BE00.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06P04-55 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06P04-60. COMPLETE INFORMATION SECTION A, 1. PATIENT IDENTIFIER = 102720001689. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S ANTI-HCV RESULTS ON ONE DONOR. THE RESULTS PROVIDED WERE: ON 04MAR2020 SID102720001689 =0.97S/CO (<1.00S/CO = NONREACTIVE) ON ALINITYS SERIAL NUMBER (SN) (B)(4). THE CUSTOMER DID NOT LIKE THE RESULT BEING CLOSE TO THE CUTOFF, SO ON 05MAR2020 THE SAMPLE WAS RETESTED ON ALINITY S SN (B)(4) AND THE RESULTS =1.20S/CO (>1.00S/CO = REACTIVE) / RETEST = 0.98 AND 1.10S/CO. THE SAMPLE WAS SENT AND TESTED BY NAT AND REALTIME PCR WITH BOTH BEING NEGATIVE. THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347578 ALINITY S ANTI-HCV REAGENT KIT ANTI-HCV QHM ABBOTT GMBH 09221BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY S SYSTEM, LIST NUMBER 06P16-01,| ALINITY S SYSTEM, LN 06P16-01,| SERIAL # (B)(6) | SERIAL NUMBER (B)(6) | ALINITY S SYSTEM, LIST NUMBER 06P16-01,| SERIAL NUMBER AS1078