BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHROMTIN SL

    MDR report key: 6730078 · Received July 20, 2017

    Report

    Report Number
    9610806-2017-00073
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 3, 2017
    Report Date
    July 31, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GFO
    UDI-DI
    00842768007521
    PMA / PMN Number
    K955450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 9610806-2017-00073 ON JULY 20, 2017. JULY 21, 2017 ADDITIONAL INFORMATION: UPON FURTHER INVESTIGATION, SIEMENS DETERMINED THAT THERE WAS NO POTENTIAL FOR DEATH OR SERIOUS INJURY FOR THIS INCIDENT. THERE IS NEGLIGIBLE POTENTIAL FOR INJURY IF THIS TYPE OF INCIDENT WERE TO RECUR. SUPPLEMENTAL MDRS 9610806-2017-00072_S1 AND 9610806-2017-00074_S1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE OPERATOR CONTACTED A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) TECHNICAL APPLICATION SPECIALIST (TAS) TO DETERMINE WHICH RESULT THEY SHOULD REPORT FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) AND WHETHER THE PATHROMTIN SL REAGENT CAN BE USED TO MONITOR LOW-MOLECULAR WEIGHT (LMW) HEPARIN THERAPY. THE OPERATOR INDICATED THAT THEY ROUTINELY USE THE ACTIN FSL REAGENT TO TEST FOR APTT AND THEY USE THE PATHROMTIN SL REAGENT SPECIFICALLY TO TEST HEPARINIZED PATIENTS AND FOR THIS PATIENT THEY OBTAINED DIFFERENT RESULTS WHEN THEY TESTED THE PATIENT'S BLOOD IN PARALLEL USING THE PATHROMTIN SL AND ACTIN FSL REAGENTS. THE OPERATOR DID NOT PROVIDE THE LOT NUMBERS OF THE PATHROMTIN SL AND ACTIN FSL REAGENTS. SIEMENS HAS DETERMINED THAT ACTIN FSL AND PATHROMTIN SL REAGENTS ARE NOT RECOMMENDED FOR MONITORING OF APTT WHEN THE PATIENT IS ON LOW-MOLECULAR WEIGHT (LMW) HEPARIN THERAPY. THE INSTRUCTION FOR USE (IFU) FOR THE ACTIN FSL AND PATHROMTIN SL REAGENTS DO NOT HAVE PERFORMANCE CLAIMS FOR MONITORING LMW HEPARIN THERAPY. SIEMENS OFFERS FOUR DIFFERENT APTT REAGENTS WHICH PROVIDE OPTIONS IN SENSITIVITY TO HEPARIN, LUPUS ANTICOAGULANTS, AND FACTOR DEFICIENCIES THAT ALLOWS CUSTOMERS TO SELECT A REAGENT TYPE THAT IS MOST APPROPRIATE FOR MONITORING THEIR SPECIFIC PATIENT POPULATION. THE VARIATION IN SENSITIVITY CAN LEAD TO DIFFERENCES IN THE APTT RESULTS ON PATIENT SAMPLES. THE INSTRUMENT AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2017-00072 AND MDR 9610806-2017-00074 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A PATIENT WAS ADMINISTERED LOW-MOLECULAR WEIGHT (LMW) HEPARIN THERAPY AFTER RECEIVING SURGERY AND TESTED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). IN PARALLEL, THE OPERATOR ANALYZED THE PATIENT BLOOD FOR APTT USING THE ACTIN FSL AND PATHROMTIN SL REAGENTS AND OBTAINED DIFFERENT APTT RESULTS. THE OPERATOR OBTAINED AN APTT RESULT OF 127.8 SECONDS USING THE PATHROMTIN SL REAGENT AND OBTAINED AN APTT RESULT OF 29 SECONDS USING THE ACTIN FSL REAGENT. IT IS UNKNOWN IF ANY RESULTS WERE REPORTED TO THE PHYSICIAN. THE OPERATOR INDICATED THEY EXPLAINED THE SITUATION TO THE PHYSICIAN SUCH THAT THESE APTT RESULTS DID NOT AFFECT THE PATIENT. THE OPERATOR INDICATED THAT THE PHYSICIAN TREATED THE PATIENT ACCORDING TO STANDARD MEDICAL PROTOCOLS AND OTHER TEST RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT APTT RESULTS OBTAINED BETWEEN THE PATHROMTIN SL AND ACTIN FSL REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510432 PATHROMTIN SL PATHROMTIN SL GFO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PATHROMTIN SL UNKNOWN 00842768007521

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR