BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183094 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05412
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE REVIEW OF THE BLACK BOX SHOWED NO EVIDENCE OF POWER ISSUES. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AND CORROSION WAS OBSERVED INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO TIGHTEN SECURELY TO THE PUMP AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE REPORTER, THE PATIENT'S MOTHER, REPORTED THE PUMP WOULD POWER OFF DURING USE. NO FURTHER INFORMATION WAS PROVIDED, AND NO TROUBLESHOOTING COULD BE DONE AS THE CUSTOMER SERVICE REPRESENTATIVE WAS UNABLE TO CONTACT THE REPORTER. THERE WAS NO ALLEGATION OF PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR