BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO 21

    MDR report key: 4254370 · Received November 13, 2014

    Report

    Report Number
    2919016-2014-00042
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    July 2, 2014
    Report Date
    October 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A DEVICE PROBLEM RELATED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS. DEVICE NOT RETURNED. THE MANUFACTURER FOLLOWED UP WITH THE CUSTOMERS AND FURTHER INVESTIGATION SUGGESTED THAT THE CUSTOMER POWER THE INSTRUMENT OFF IN THE EVENING. WHEN TURNING IT BACK ON THE CUSTOMER ALLOWED BETWEEN 30 TO 60 MINUTES FOR THE SYSTEM TO WARM UP. THE CUSTOMER WAS REMINDED TO FOLLOW THE OPERATORS MANUAL TO WARM UP THE INSTRUMENT UP TO 60 MINUTES. ON (B)(6) 2014, THE CUSTOMER REPEATED THE TEST USING PC 21 PANEL (LOT 2015-04-15) AND THE SYSTEM THE INTERPRETATION RESULTS MATCHED WITH THE API EXPECTED RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RAN AN API SURVEY ISOLATE FROM AN URINE SAMPLE AND RECOVERED AN IDENTIFICATION OF E. FAECALIS USING POS COMBO 21 PANEL (LOT 2014-08-27) ON (B)(6)2014. MULTIPLE ANTIMICROBICS GAVE FALSE SUSCEPTIBLE/LOWERED MINIMAL INHIBITORY CONCENTRATION ( MIC). THE CUSTOMER REPEATED THE TESTING ON (B)(6) 2014 FOR THE SAME ISOLATE USING PC21 PANEL (LOT 2015-04-15) AND AGAIN RECOVERED AN IDENTIFICATION OF E. FAECALIS WITH MULTIPLE ANTIMICROBICS GAVE FALSE SUSCEPTIBLE/LOWERED MINIMAL INHIBITORY CONCENTRATION (MIC). THERE WAS NO PATIENT INVOLVED AS THIS WAS A PROFICIENCY SURVEY ISOLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733120 POS COMBO 21 POS COMBO 21 LRG SIEMENS HEALTHCARE DIAGNOSTICS, INC. B1017-201 2015-04-15

    Patients

    Seq Age Sex Outcome Treatment
    1