BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221369 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31284
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 06/02/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 05/15/2015 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP HISTORY REVEALED POTENTIAL EVIDENCE OF SHORT BATTERY LIFE. THE BLACK BOX DATA FROM THE EVENT DATE HAD BEEN OVERWRITTEN DUE TO CONTINUED PUMP USE. THE RETURNED BATTERY CAP WAS FOUND TO BE FREE OF DAMAGE. THE RETURNED BATTERY CAP WAS ABLE TO SECURE TO THE SUSPECT PUMP CASE PER THE INSTRUCTIONS FOR USE (IFU). THE BATTERY CAP CONTACT MEASUREMENTS WERE FOUND TO BE WITHIN THE SPECIFICATIONS. EVALUATION REVEALED THAT THE PUMP DREW ELECTRIC CURRENT AT LEVELS WITHIN THE SPECIFICATIONS: THE REPORTED ISSUE WAS NOT DUPLICATED. DURING THE ANALYSIS, THE PUMP OPERATED ACCORDING TO THE SPECIFICATIONS. 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 A POWER (BATTERY LIFE W/ DAMAGE) ISSUE. THE REPORTER ALLEGED THAT BATTERY LIFE WAS SHORTER THAN EXPECTED. IN ADDITION, IT WAS REPORTED THAT THE THREADS OF THE BATTERY CAP WERE STRIPPED. 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
    701443 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR