BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760828 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10672
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 05/19/2014. DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/09/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THE PUMP POWERS WITH RETURNED BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF LOWER OR CALL SERVICE ALARMS DUPLICATED. THE HEIGHT AND WIDTH OF BATTERY CAP WERE WITHIN SPECIFICATIONS. THERE WERE MULTIPLE POWER ON RESET EVENTS OBSERVED IN BLACK BOX ON 04/05/2014. THERE WAS EVIDENCE OF DISCHARGED BATTERIES BEING INSTALLED PRIOR TO THE POWER ON RESET EVENTS. BATTERY VOLTAGE AT TIME OF EAW 128 REPLACE BATTERY ALARMS, VP73.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. 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
    239657 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR