BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2111105 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03869
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 07/21/2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 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.

    Additional Manufacturer Narrative · 1

    THE PUMP AND THE CARTRIDGE HAVE NOT BEEN RETURNED TO ANIMAS. 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).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION 05/16/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO DATA IN THE BLACK BOX OR DOWNLOAD HISTORIES FROM THE TIME OF THE REPORTED INCIDENT DUE TO CONTINUED PUMP USE. A REVIEW OF THE CURRENT TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. INVESTIGATION COULD NOT BE ADEQUATELY COMPLETED DUE TO UNRESPONSIVE KEYPAD BUTTONS.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS BETWEEN 340MG/DL AND 350MG/DL WITH NO SIGNS OR SYMPTOMS. THIS DOES NOT MEET ANIMAS' CRITERIA FOR AN ADVERSE EVENT. THE PATIENT DID A SITE CHANGE, BOLUSED AND THE BG WENT DOWN TO 222MG/DL. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY WITH THE FAMILY MEMBER AND THERE WERE TWO EMPTY CARTRIDGE ALARMS. THE BOLUS HISTORY MATCHED THE TOTAL DAILY DOSE. THE PUMP WAS SUSPENDED FOR NO MORE THAN ONE HOUR. THERE WAS A SMALL BUBBLE AT THE TOP OF THE CARTRIDGE. THE FAMILY MEMBER STATED THAT THE PATIENT WAS GOING THROUGH A GROWTH SPURT. THE PATIENT CONTINUES TO USE THE PUMP WITH NO FURTHER REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE SMALL BUBBLE FOUND AT THE TOP OF THE CARTRIDGE.

    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 14 YR