BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4212149 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30821
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 01/05/2014 - DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/10/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN AND THE BATTERY COMPARTMENT INTACT. THERE WAS EVIDENCE OF PARTIALLY DISCHARGED BATTERIES BEING INSTALLED OBSERVED IN THE PUMP'S BLACK BOX. THERE WAS NO EVIDENCE OF A CALL SERVICE ALARM IN THE BLACK BOX OR ALARM HISTORY. THE PUMP'S CURRENT DRAWS WERE WITHIN SPECIFICATIONS. NO BATTERY LIFE ISSUES WERE DUPLICATED DURING THE INVESTIGATION. THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE PUMP. 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.

    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 THAT THE PUMP WAS EXPERIENCING SHORTER THAN EXPECTED BATTERY LIFE. 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
    692369 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR