BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HAVAB IGG

    MDR report key: 7710817 · Received July 23, 2018

    Report

    Report Number
    3002809144-2018-00087
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Report Date
    November 16, 2018
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS DETERMINED THAT THERE ARE NO ADDITIONAL COMPLAINTS FOR LOT 87322LI00 AND THERE ARE NO TRENDS IDENTIFIED FOR THE COMPLAINT ISSUE. SPECIFICITY TESTING WAS PERFORMED WITH A RETAINED KIT OF LOT 87322LI00 AND THE RESULTS DID NOT INDICATE THAT THE SPECIFICITY PERFORMANCE OF THE LOT WAS IMPACTED, AS NO FALSE REACTIVE RESULTS WERE OBTAINED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF LABELING WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY I HAVAB IGG REAGENT, LOT NUMBER 87322LI00.

    Additional Manufacturer Narrative · 0

    THE EVENT DOCUMENTED HAS BEEN ASSOCIATED WITH A PRODUCT RECALL. THE EVENT ASSOCIATED WITH THE SUSPECT MEDICAL DEVICE ALINITY I HAVAB IGG REAGENTS IS NOT REPORTABLE PER 21CFR PART 806, AS THE PRODUCT HAS NOT BEEN DISTRIBUTED IN THE US. NO FURTHER FOLLOW UPS WILL BE PROVIDED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P26 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L27.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I HAVAB IGG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) = 1.11S/CO (>/=1.00S/CO = REACTIVE) / 0.4S/CO (<1.00S/CO = NONREACTIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553230 ALINITY I HAVAB IGG IGG ANTI-HAV LOL ABBOTT GERMANY 87322LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 03R65-01, SERIAL # (B)(4)| ALINITY I PROCESSING MODULE: LIST #| ALINITY I PROCESSING MODULE: LIST #03R65-01,| ALINITY I PROCESSING MODULE: LIST #03R65-01,| SERIAL # (B)(4)| SERIAL # (B)(4)| 03R65-01, SERIAL # (B)(4)| ALINITY I PROCESSING MODULE: LIST #