BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6031441 · Received October 14, 2016

    Report

    Report Number
    2531779-2016-28594
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 12/14/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/17/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED MULTIPLE CALL SERVICE 006 ELECTRONICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY (EEPROM) WRITE FAILURE ALARMS. THE BATTERY COMPARTMENT AND THE CAP WERE UNDAMAGED AND WERE ABLE TO FIT SECURELY. THE PUMP POWERED UP TO A CALL SERVICE 069 ALARM. CALL SERVICE 069 IS DEFINED AS AN EEPROM CORRUPTION FOR THE ONE TOUCH PING PUMP. THE KEYPAD BUTTONS AND THE DISPLAY WERE UNABLE TO BE INVESTIGATED. THE REPORTED EEPROM FAILURE WAS DUPLICATED. THE PUMP COVER WAS REMOVED TO FIND THE UPPER EEPROM COMPONENT TO BE CRACKED. FURTHER TESTING WAS NOT ABLE TO BE PERFORMED. EVALUATION REVEALED THAT THE EEPROM COMPONENT HAD FAILED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM 006-0001 ISSUE; THE ALARM OCCURRED 3 TIMES IN 30 DAYS. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681817 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR