BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY LIPASE REAGENT (LIP)

    MDR report key: 9577750 · Received January 10, 2020

    Report

    Report Number
    2432235-2020-00025
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    October 31, 2019
    Report Date
    January 21, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2432235-01/02/2020-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR 2432235-2020-00025 WAS FILED ON 10-JAN-2020. CORRECTED INFORMATION (14-JAN-2020): CORRECTED DATE OF FIRST EVENT ((B)(6) 2019). ADDITIONAL INFORMATION (17-JAN-2020): SIEMENS WAS NOTIFIED BY THE CUSTOMER THAT THE LABORATORY CONTINUES TO PROCESS LIPASE SAMPLES ACCORDING TO SIEMEN'S RECOMMENDATIONS ON WORKING REAGENT BOXES. SECTIONS B3 AND B5 WERE UPDATED.

    Description of Event or Problem · 0

    THE LABORATORY CONTINUES TO PROCESS LIPASE SAMPLES ACCORDING TO SIEMEN'S RECOMMENDATIONS ON WORKING REAGENT BOXES.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS, INC. HAS RECEIVED CUSTOMER COMPLAINTS REGARDING FAILED CALIBRATIONS AND INCREASED IMPRECISION OF QUALITY CONTROL AND PATIENT SAMPLES WHEN USING ADVIA CHEMISTRY LIPASE REAGENT LOT 485700. PRELIMINARY INVESTIGATION HAS INDICATED THAT NOT ALL CARTONS WITHIN THIS REAGENT LOT ARE IMPACTED. AN URGENT MEDICAL DEVICE RECALL (UMDR) CHC 20-03.A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) CHC 20-03.A.OUS WAS SENT TO OUS CUSTOMERS IN DECEMBER 2019. THE UMDR AND UFSN ADVISE CUSTOMERS OF THE INVESTIGATION WITH THE ADVIA CHEMISTRY LIPASE REAGENT LOT 485700 AND PROVIDE INSTRUCTIONS TO HELP DETERMINE IF THE LIPASE REAGENT CARTONS IN THEIR INVENTORY ARE IMPACTED. IF THE CARTONS IN THE CUSTOMERS INVENTORY ARE NOT IMPACTED, THE CUSTOMERS ARE INSTRUCTED TO PROCEED TO USING THE CARTONS ACCORDING TO THE INSTRUCTIONS FOR USE. IF THE CARTONS IN THE CUSTOMERS INVENTORY ARE IMPACTED, THE CUSTOMERS ARE INSTRUCTED TO DISCARD THE IMPACTED CARTONS AND CAN REQUEST REPLACEMENT. THE NEXT REAGENT LOT IS EXPECTED TO BE AVAILABLE BY FEBRUARY 2020. IF REPLACEMENT KITS ARE NOT AVAILABLE, CUSTOMERS ARE INSTRUCTED TO TEST PATIENT SAMPLES USING AN ALTERNATE METHODOLOGY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THAT IMPRECISION WERE OBSERVED FOR LIPASE (LIP) KIT LOT 485700 WHILE USING AN ADVIA 1800 INSTRUMENT. BASED ON THE PERFORMANCE OF QC AND THE PRECISION STUDY, THE CUSTOMER IS NOT USING THIS REAGENT LOT FOR PATIENT TESTING. SAMPLES ARE BEING SENT TO AN ALTERNATE LABORATORY FOR TESTING. CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISION OBSERVED WITH THE LIP ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36726 ADVIA CHEMISTRY LIPASE REAGENT (LIP) ADVIA CHEMISTRY LIPASE REAGENT (LIP) CHI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY LIPASE (LIP) 485700

    Patients

    Seq Age Sex Outcome Treatment
    1