BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2955271 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01682
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 26, 2013
    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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: AN "EZPRIME" OPERATION WAS PERFORMED WITH NO DIFFICULTIES NOTED. A REVIEW OF THE BLACK BOX AND PUMP HISTORIES SHOWS NO TIME/DATE RESETS OR DUPLICATE TIME/DATES IN THE RECORDED DATA. 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. INVESTIGATORS WERE UNABLE TO ADEQUATELY INVESTIGATE THE TIME LOSS/GAIN COMPLAINT DUE TO A DEFECTIVE BT1 FAILURE ON THE BENCH.

    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 PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PUMP TIME RESETS ITSELF. THE PATIENT DENIED ANY TIME AND DATE RESET DURING BATTERY CHANGE. THE PATIENT STATED THAT THE TIME RANDOMLY RESETS ON ITS OWN. CUSTOMER SUPPORT INSTRUCTED THE PATIENT TO DISCONNECT AND REBOOT TO CHECK IF TIME AND DATE RESET AND IT DID NOT. THE PATIENT CONFIRMED THAT SHE NEVER HAD TO RESET THE TIME AND DATE HOWEVER, TWICE THE TIME WAS OFF BY 12 HOURS. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE TIME LOSS/GAIN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58661 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR