BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3852489 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15962
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/17/2014. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/12/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND EVIDENCE OF SHORT BATTERY LIFE WITH MULTIPLE LOW AND REPLACE BATTERY WARNINGS IN ALARM HISTORY. INVESTIGATION FOUND THAT THE THREADS AREA OF THE BATTERY COMPARTMENT WAS CRACKED AND THE COIN SLOT ON THE BATTERY CAP WAS STRIPPED. THE PUMP POWER ON 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 AND NO EVIDENCE OF MOISTURE INTRUSION WAS FOUND INSIDE THE PUMP. THE REPORTED BATTERY LIFE ISSUE WAS VERIFIED IN THE BLACK BOX AND THE CAP/CASING ISSUE WAS CONFIRMED DURING 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 W/ DAMAGE) ISSUE. REPORTEDLY, THE BATTERY LIFE WAS LESS THAN EXPECTED. THE BATTERY CAP WAS ALLEGEDLY WORN AND THE BATTERY COMPARTMENT WAS DAMAGED. THE REPORTER STATED THAT THERE WAS NO EVIDENCE OF MOISTURE/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
    329316 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR