BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4862552 · Received June 23, 2015

    Report

    Report Number
    2531779-2015-20730
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    June 6, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    FOLLOW-UP #1; DATE OF SUBMISSION: 08/17/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 07/24/2015 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED FROM THE THREADS TO THE CASE SEAL. CORROSION WAS FOUND ON THE INSIDE OF THE BATTERY COMPARTMENT; THIS DEVICE FAILURE CAUSED THE POWER FAILURE. THE PUMP FAILED TO POWER ON, AS CONFIRMED BY THE ABSENCE OF THE AUDITORY CUE, VIBRATORY CUE, AND VISUAL DISPLAY; THE REPORTED ISSUE WAS DUPLICATED. THE PUMP FAILED A LEAK TEST DUE TO A BATTERY COMPARTMENT LEAK; THIS DEVICE FAILURE CAUSED THE MOISTURE INGRESS ISSUE. THE PUMP CASE WAS REMOVED, AND FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND ON THE BATTERY CANISTER. THE REPORTED ISSUES WERE CONFIRMED DURING THE ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS DISPLAYING A NO-POWER ISSUE, WHICH IS IDENTIFIED BY THE ABSENCE OF THE AUDITORY CUES, VIBRATORY CUES, AND VISUAL DISPLAY IMAGE UPON ATTEMPTED USE. IN ADDITION, IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED. FURTHERMORE, IT WAS REPORTED THAT EVIDENCE OF MOISTURE INGRESS WAS OBSERVED INSIDE OF THE BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED 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
    405958 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR