BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3790615 · Received May 5, 2014

    Report

    Report Number
    2531779-2014-12490
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MULTIPLE LOW BATTERY WARNINGS ALONG WITH EVIDENCE OF A PARTIALLY DISCHARGED BATTERY BEING INSTALLED A WEEK BEFORE THE COMPLAINT DATE. NO DAMAGE TO THE BATTERY COMPARTMENT AND CAP WAS OBSERVED. THE PUMP POWERED UP WITH THE RETURNED BATTERY CAP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENTS. THE ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE PUMP CASING WAS OPENED TO FURTHER INVESTIGATE. THERE WAS NO EVIDENCE OF EVIDENCE OF MOISTURE INTRUSION OR LOOSE COMPONENTS INSIDE THE PUMP. THE REPORTED POWER ISSUE WAS VERIFIED IN THE BLACK BOX BUT WAS NOT DUPLICATED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. REPORTEDLY, THE BATTERY LIFE WAS LESS THAN EXPECTED AND ALARM HISTORY SHOWED RECURRING LOW BATTERY WARNINGS. THE REPORTER NOTED THAT THE ISSUE RECURRED WITH NEW BATTERIES FROM DIFFERENT PACKS. THE REPORTER STATED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. 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
    268490 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR