BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2823301 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13254
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 05/28/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/20/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA SHOWED DATE CHANGES IN THE TOTAL DAILY DOSAGE HISTORY, BUT NO DATA IN THE BLACK BOX DUE TO CONTINUED CUSTOMER USE. THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FUNCTIONS. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENTS. A TIME KEEPING ACCURACY TEST WAS PERFORMED AND IT MET SPECIFICATIONS. THE PUMP CASING WAS OPENED TO FURTHER INVESTIGATE AND THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD WAS FOUND TO HAVE MALFUNCTIONED. 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

    ON (B)(6) 2012, THE PATIENT'S MOTHER CONTACTED ANIMAS AND LEFT A MESSAGE WITH THE ANSWERING SERVICE ALLEGING THAT THE PUMP WAS NOT HOLDING INFORMATION AND IT KEPT SWITCHING THE DATES. NO ADDITIONAL INFORMATION WAS PROVIDED. IN ADDITION THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO REACH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION AND REVIEW THE SUBJECT PUMP; HOWEVER, WERE UNSUCCESSFUL IN THEIR ATTEMPTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    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 7 YR