BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2050434 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02287
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER GRANDDAUGHTER ALLEGING ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE REPORTER INDICATED THAT THE PT'S BG LEVELS HAVE BEEN RUNNING BETWEEN "200-250 MG/DL." THE REPORTER DENIED THAT THE PT HAD ANY SYMPTOMS. TROUBLESHOOTING REVEALED THAT THE PUMP DELIVERED 29.516 UNITS OF INSULIN THE DAY BEFORE ALTHOUGH, THE PUMP WAS SET TO DELIVER 32.486 UNITS/24 HOURS. THE PUMP WAS NOT REPORTEDLY SUSPENDED AND NO TEMPORARY BASALS WERE SET. THE REPORTER CLAIMED THAT THE BOLUSES WERE CORRECT. NO ASSOCIATED ALARMS WERE NOTED IN THE ALARM HISTORY. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PUMP DID NOT DELIVER INSULIN AS PROGRAMMED FOR A 24 HOUR PERIOD. THERE IS NO EVIDENCE HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PT DID NOT HAVE ANY BG READINGS OR SYMPTOMS THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1