BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760430 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10650
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP BLACK BOX SHOWED DATES FROM (B)(6) 2014. THERE WERE NO UNEXPLAINABLE PUMP REBOOTS OBSERVED IN THE BLACK BOX. THE PUMP POWERED ON NORMALLY WITH THE RETURNED BATTERY CAP. THE BATTERY CAP THREADS WERE OBSERVED TO BE DAMAGED AND THE CAP WAS UNABLE TO FULLY TIGHTEN TO THE PUMP. THE BATTERY COMPARTMENT WAS CRACKED IN THE THREAD AREA AND BELOW GRIP PAD. THE BATTERY COMPARTMENT THREADS WERE ALSO DAMAGED. A POWER LOSS WAS NOT OBSERVED. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOTS, LOSS OF POWER OR CALL SERVICE ALARMS OCCURRING. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. THE ISSUE OF NO POWER WAS NOT DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO 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
    240605 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR