BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895808 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18391
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/11/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF EXCESSIVE BATTERY USAGE OR SHORT BATTERY LIFE OBSERVED IN THE BLACK BOX DATA. THE BATTERY COMPARTMENT WAS OBSERVED TO BE INTACT. THE PUMP POWERED UP PROPERLY WITH THE RETURNED BATTERY CAP, WHICH WAS ABLE TO FULLY FASTEN TO THE PUMP. EVALUATION REVEALED THAT THE PUMP DREW ELECTRICAL CURRENT WITHIN THE SPECIFICATIONS; THE EVENT REPORTED IN THE INITIAL COMPLAINT WAS NOT DUPLICATED. UNRELATED TO THE REPORTED EVENT, EVIDENCE OF MOISTURE INGRESS WAS OBSERVED ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP CASE WAS REMOVED AND NO FURTHER EVIDENCE OF MOISTURE INGRESS WAS OBSERVED ON INTERNAL COMPONENTS. ALSO UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) ISSUE. REPORTEDLY, THE BATTERY LIFE WAS LESS THAN EXPECTED WITH MULTIPLE BATTERIES FROM DIFFERENT PACKS. IT WAS REPORTED THAT THE THREADS ON THE BATTERY CAP WAS STRIPPED. THE REPORTER STATED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT AND 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
    371708 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR