BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4191357 · Received October 21, 2014

    Report

    Report Number
    2531779-2014-29841
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    October 6, 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 11/28/2014 ¿ DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/12/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT TWO ¿SUSPEND¿ EVENTS ON 09/30/2014 AND 10/05/2014. NO IRREGULAR DATA WAS OBSERVED. THE BATTERY COMPARTMENT WAS INTACT; NO DAMAGE WAS OBSERVED. THE KEYPAD COVER WAS FOUND TO BE FULLY INTACT; NO DAMAGE WAS OBSERVED. DURING TESTING, ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. THERE WAS NO EVIDENCE OF HYPERSENSITIVE OR STUCK/INTERMITTENT KEY RESPONSES OBSERVED. THE PUMP WAS SUSPENDED AND RESUMED MULTIPLE TIMES WITH NO ISSUES OCCURRING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO SUSPEND, POWER REBOOTS, POWER LOSSES, OR CALL SERVICE ALARMS OCCURRING. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF ADDITIONAL MOISTURE OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. THE COMPLAINT THAT THERE WAS AN ISSUE WITH THE SUSPEND FEATURE WAS NOT ABLE TO BE DUPLICATED DURING 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 THAT THERE WAS AN ISSUE WITH THE SUSPEND FEATURE. 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
    669253 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR