BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C-I SERIES SYSTEM

    MDR report key: 7732609 · Received July 30, 2018

    Report

    Report Number
    3002809144-2018-00099
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Report Date
    August 13, 2018
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137410
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN EMDR WAS SUBMITTED ON JULY 30, 2018 BASED ON INFORMATION AVAILABLE AT THAT TIME. CLARIFICATION OF THE COMPLAINT ISSUE WAS PROVIDED ON AUGUST 2, 2018. THE ISSUE WAS CLARIFIED TO BE CAUSED BY THE BYG SOFTWARE WHICH IS NON-ABBOTT MIDDLEWARE. THE ALINITY CI ANALYZER GENERATED CORRECT RESULTS AND CORRECTLY TRANSMITTED THOSE RESULTS TO THE BYG MIDDLEWARE. BYG MISINTERPRETED THE ALINITY RESULTS. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE AND NO PRODUCT EVALUATION WILL BE PERFORMED. THE ALINITY RESULTS ARE CORRECT : 50000 AND 50916 PG/ML AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A DATA TRANSCRIPTION ERROR BY THE BYG SOFTWARE ON THE ALINITY CI ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(4) HAD A TROPONIN RESULT SENT AS 50,916 PG/ML, REPORTED AS <10. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572939 ALINITY C-I SERIES SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT GERMANY 00380740137410

    Patients

    Seq Age Sex Outcome Treatment
    1 LN UNKNOWN LOT UNKNOWN| LN UNKNOWN LOT UNKNOWN| TROPONIN REAGENTS| TROPONIN REAGENTS