BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3913929 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18941
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND RECORDS OF THE REPORTED CALL SERVICE ALARM ON THE EVENT DATE. MOISTURE WAS EVIDENT BEHIND THE DISPLAY. THE PUMP POWERED UP WITH AUDIBLE BUT NO VIBRATORY FEATURE. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. BOLUS EXERCISE WERE COMPLETED AND RECORDED CORRECTLY. INVESTIGATION WAS UNABLE TO COMPLETE A 24-HOUR PUMP EXERCISE DUE TO ALARM RELATED TO SOFTWARE TESTING ISSUE. A CRACK WAS FOUND ON THE PUMP CASING IN THE DISPLAY AREA AND A LEAK TEST SHOWED THE PUMP WAS LEAKING WHERE THE CRACK WAS LOCATED. THE PUMP CASING WAS OPENED TO FURTHER INVESTIGATE AND MOISTURE INTRUSION WAS FOUND ON MULTIPLE INTERNAL COMPONENTS. THE REPORTED CALL SERVICE ALARM ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATE IN THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP ALARMED FOR CALL SERVICE 060 JUST AFTER THE PATIENT CAME IN FROM SWIMMING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390332 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR