BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172762 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05129
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THAT BATTERY CAP WAS NOT RETURNED WITH THE PUMP. NO PHYSICAL DAMAGE WAS OBSERVED ON THE PUMP. A TEST BATTERY CAP WAS USED FOR EVALUATION AND WAS ABLE TO PROPERLY SECURE TO THE PUMP. THE PUMP BOOTED UP PROPERLY AND WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE PUMP EMITTED AN EMPTY CARTRIDGE ALARM ON (B)(6) 2011. NO ACTION WAS TAKEN BY THE USER AND THE PUMP POWERED OFF ON 6/3/11. THIS IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP HAD NO POWER ON (B)(6) 2011. HE STATED THAT HE TRIED NEW BATTERIES FROM TWO DIFFERENT PACKAGES WITH NO RESOLUTION TO THE ISSUE. HE CONFIRMED THAT THERE IS NO STRUCTURAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT, AND DENIED CORROSION IN THE BATTERY COMPARTMENT. THE FAMILY MEMBER STATED THAT THE PATIENT DOES NOT EXPOSE THE PUMP TO WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR