BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 25180610 · Received May 15, 2026

    Report

    Report Number
    9610806-2026-00012
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 19, 2026
    Report Date
    May 15, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    UDI-DI
    00842768003882
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FLAGGED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) RESULT OBTAINED ON A PATIENT SAMPLE ON CS-2500 INSTRUMENT. BASED ON THE REVIEW OF INFORMATION PROVIDED, NO CLOT FORMATION TOOK PLACE WITHIN THE WHOLE MEASUREMENT TIME EVEN UP TO 360 SEC. THE DRIFT OF THE BASELINE IS UNSPECIFIC. THE SAMPLE WAS CORRECTLY FLAGGED. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES ON THE DAY OF THE EVENT. THE FLAGGED RESULT COULD BE CAUSED BY LDL IN COMBINATION WITH A HIGH CRP OR PROPOFOL TREATMENT. THE CUSTOMER IS OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FLAGGED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) RESULT OBTAINED ON A PATIENT SAMPLE ON CS-2500 INSTRUMENT. THE FLAGGED RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE PATIENT RESULT, AND THE LABORATORY REPEATED THE MEASUREMENT ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULT WAS LONGER THAN THE ERRONEOUS REPORTED RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS REPORTED APTT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534259 DADE ACTIN FSL ACTIVATED PTT REAGENT TEST, TIME, PARTIAL THROMBOPLASTIN GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 562798 00842768003882

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female