BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FS ACTIVATED PTT REAGENT

    MDR report key: 22584913 · Received July 24, 2025

    Report

    Report Number
    9610806-2025-00027
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 28, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    UDI-DI
    00842768003868
    PMA / PMN Number
    K811589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2025-00027 ON 2025-07-24. ADDITIONAL INFORMATION 2025-07-11: SIEMENS HEALTHINEERS INVESTIGATION INCLUDED A REVIEW OF THE PATIENT INFORMATION INCLUDING THE RESULTS OBTAINED, INSTRUMENT PERFORMANCE AND A TESTING OF THE PROVIDED PATIENT SAMPLE. QC RESULTS HAVE BEEN FOUND WITHIN RANGE ON THE DAYS THE RESULTS IN QUESTION WERE OBSERVED. APPLICATION SETTING (APTT WITH ACTIN FS) HAS BEEN CHECKED AND IS IN ALIGNMENT WITH REFERENCE GUIDE OF THE USED INSTRUMENT. INTERNAL TESTING OF PROVIDED PATIENT SAMPLE COULD NOT REPRODUCE CUSTOMER OBSERVATION THAT PATIENT SAMPLE RESULTS DO NOT MATCH HEPARIN THERAPY. DUE TO THE PATIENT'S CLINICAL PICTURE AND THE BROAD MEDICATION, IT CANNOT BE COMPLETELY RULED OUT THAT THE SAMPLE INTEGRITY HAS AN INFLUENCE ON THE APTT TEST RESULT. THEREFORE, THE DESCRIBED LIMITATIONS OF PROCEDURE WITHIN THE RELATED IFU OF ACTIN FS SHOULD BE TAKEN INTO CONSIDERATION:IT SHOULD BE NOTED THAT APTT TESTING MAY BE AFFECTED BY A NUMBER OF COMMONLY ADMINISTERED DRUGS. DECREASE IN TIME OF APTT DETERMINATION IN CONJUGATED ESTROGEN THERAPY IN MALES AND ORAL CONTRACEPTIVE ADMINISTRATION IN FEMALES HAS BEEN REPORTED. INCREASE IN THE APTT HAS BEEN SEEN IN DIPHENYLHYDANTOIN, HEPARIN, WARFARIN, NALOXONE AND RADIOGRAPHIC AGENT ADMINISTRATION, THERAPEUTIC DOSES OF HIRUDIN OR OTHER DIRECT THROMBIN INHIBITORS MAY PROLONG CLOTTING TIMES. LIPOGLYCOPEPTIDE ANTIBACTERIAL DRUGS (SUCH AS ORITAVANCIN OR TELAVANCIN) MAY INTERFERE WITH APTT BASED ASSAYS. CONSULT INSTRUCTIONS FOR USE OF RESPECTIVE DRUGS. IN ADDITION, THE CHOICE OF ANTICOAGULANT (I.E. CITRATE VS. OXALATE) AND THE CONDITION OF THE SPECIMEN (E.G. HEMOLYZED, LIPEMIC, PARENTERAL FEEDING, ETC.) MAY AFFECT RESULTS. THE LATTER IS PARTICULARLY TRUE OF OPTICAL INSTRUMENTATION MEASUREMENTS OF THE APTT. BLOOD CLOTTING FACTOR DEFICIENCIES WHICH SHOULD PRODUCE PROLONGED CLOTTING TIMES MAY BE COMPENSATED FOR OR MADE TO APPEAR NORMAL BY ELEVATED LEVELS OF ONE OR MORE DIFFERENT CLOTTING FACTORS. SIMILARLY, THE PRESENCE OF ACTIVE INTERMEDIATES WHICH WOULD TEND TO REDUCE THE CLOTTING TIME MAY ALSO MASK CONDITIONS THAT WOULD NORMALLY LEAD TO PROLONGATION OF THE APTT. MILD OR MINOR DEFICIENCIES IN SEVERAL FACTORS MAY HAVE AN ADDITIVE EFFECT ON INCREASING THE APTT. ACTIN FS MAY PROVIDE VARIABLE APTT RESULTS IN SAMPLES CONTAINING THE LUPUS-LIKE ANTICOAGULANT. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE CAUSE OF THE DISCORDANT RESULTS IS CONSISTENT WITH A SAMPLE SPECIFIC BEHAVIOR. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. CUSTOMER IS OPERATIONAL. CROSS-REFERENCE RELATED MDRS FOR THE SAME PATIENT: MDR 9610806-2025-00025 WAS FILED FOR THE DISCORDANT RESULTS WITH THE SAME PATIENT ON (B)(6) 2025. MDR 9610806-2025-00026 WAS FILED FOR THE DISCORDANT RESULTS WITH THE SAME PATIENT ON (B)(6) 2025. MDR 9610806-2025-00028 WAS FILED FOR THE DISCORDANT RESULTS WITH THE SAME PATIENT ON (B)(6) 2025. MDR 9610806-2025-00029 WAS FILED FOR THE DISCORDANT RESULTS WITH THE SAME PATIENT ON(B)(6) 2025. MDR 9610806-2025-00030 WAS FILED FOR THE DISCORDANT RESULTS WITH THE SAME PATIENT ON (B)(6) 2025.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT APTT RESULTS THAT WERE OBTAINED ON ONE PATIENT SAMPLE ON THE CA-660 INSTRUMENT. SIEMENS HEALTHINEERS IS INVESTIGATING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT NORMAL APTT (SEC) RESULTS COMPARED TO AN ALTERNATE METHOD AS PATIENT IS TREATED WITH UNFRACTIONATED HEPARIN. THE PATIENT SAMPLE WAS MEASURED WITH DADE ACTIN FS ACTIVATED PTT REAGENT ON THE CA-660 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717638 DADE ACTIN FS ACTIVATED PTT REAGENT TEST, TIME, PARTIAL THROMBOPLASTIN GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FS ACTIVATED PTT REAGENT 562471A 00842768003868

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male