BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2180364 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05329
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    June 27, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/30/2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/01/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP'S HISTORY INDICATED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2011 AT 10:44 AM. THE HISTORY INDICATED THAT THE PUMP WAS "EE WIPED" ON (B)(6) 2011 AT 7:06 PM. THIS FUNCTION IS ACTIVATED BY SIMULTANEOUSLY PRESSING THE CONTRAST BUTTON AND THE AUDIO BOLUS BUTTON. THERE WERE NO BASAL DELIVERY RECORDS FROM (B)(6) 2011 10:44 PM TO (B)(6) 2011 7:06 PM. DURING INVESTIGATION, THE PUMP POWERED ON TO THE VERIFICATION SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THERE WERE NO DEFECTS FOUND ON INVESTIGATION.

    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. (B)(6).

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT THE SETTINGS AND HISTORIES IN THE PUMP WERE DELETED AFTER A FAMILY MEMBER REPLACED THE BATTERY. SHE REPORTED THAT THE PUMP DISPLAYED ONE OF THE FOLLOWING MESSAGES: "DELETING EE" OR "ERASING EE". SHE NOTED THAT ALL SETTINGS AS WELL AS THE PUMP HISTORY RECORDS WERE DELETED FROM THE PUMP. THE PATIENT WAS PLACED ON AN ALTERNATIVE METHOD OF INSULIN DELIVERY; THERE WERE NO REPORTS OF BLOOD GLUCOSE EXCURSIONS ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THIS ALLEGED MALFUNCTION MIGHT CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR BUT ONLY IF A USER DID NOT NOTICE THE WARNINGS EMITTED BY THE PUMP.

    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 10 YR