BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGIVAL INSTRUMENT (OUS)

    MDR report key: 23292076 · Received October 15, 2025

    Report

    Report Number
    1221359-2025-00439
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    January 1, 2025
    Report Date
    February 10, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    PSZ
    UDI-DI
    00811877010623
    PMA / PMN Number
    K162642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER LFR-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER LFR-024. B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATES WERE NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER LFR-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER LFR-024. B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATES WERE NOT PROVIDED. CORRECTED DATA: G4 - PMA/510(K) #. INVESTIGATION SUMMARY: AN INVESTIGATION WAS PERFORMED BY ABBOTT DIAGNOSTICS SCARBOROUGH, INC. IN WHICH THE INSTRUMENT POWER CABLE WAS CONFIRMED TO BE DAMAGED/FRAYED UPON REVIEW OF A CUSTOMER PROVIDED IMAGE. THE DAMAGE WAS DETERMINED TO BE CAUSE BY USER MISHANDLING AND NO PRODUCT DEFECT WAS FOUND. DAMAGED CORDS PRESENT NO DANGER TO THE USER. THE SUPPLY OUTPUT IS 12V AND THE DESIGN CONTAINS A FAILSAFE WHICH SHUTS DOWN THE SUPPLY IN THE EVENT OF ELECTRICAL SHORT CIRCUIT RESULTING FROM EXPOSED WIRING. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE POWER CORD INSULATION WAS TORN, EXPOSING THE WIRE WITHIN AND THAT THE CORD SPARKED FROM THE DAMAGED AREA OF THE DIGIVAL INSTRUMENT POWER CORD ON AN UNKNOWN DATE. AN ABBOTT FIELD SUPPORT REPRESENTATIVE CONFIRMED THAT THERE HAVE BEEN NO HEALTH PROBLEMS OR ANY HARM/INJURY TO THE CUSTOMER AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE POWER CORD INSULATION WAS TORN, EXPOSING THE WIRE WITHIN AND THAT THE CORD SPARKED FROM THE DAMAGED AREA OF THE DIGITAL INSTRUMENT POWER CORD ON AN UNKNOWN DATE. AN ABBOTT FIELD SUPPORT REPRESENTATIVE CONFIRMED THAT THERE HAVE BEEN NO HEALTH PROBLEMS OR ANY HARM/INJURY TO THE CUSTOMER AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004916 DIGIVAL INSTRUMENT (OUS) DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 00811877010623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown