BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1984498 · Received February 1, 2011

    Report

    Report Number
    2531779-2011-00573
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. A LOSS OF PRIME WAS RECORDED IN THE BLACK BOX DUE TO AN UNIDENTIFIED LOW FORCE ON (B)(6) 2011 AT 12:11 PM WHEN THE INSULIN REMAINING REACHED 68 UNITS. THE LOSS OF PRIME WARNING WAS CONFIRMED BY THE USER 31 TIMES BETWEEN 12:11 PM AND 1:35 PM. AT 1:47 PM, A 68 UNIT PRIME WAS RECORDED WHICH TRIGGERED AN EMPTY CARTRIDGE ALARM. AN ALARM OVERRIDES THE PRIME RECORD WHEN RECORDING AND IS THE REASON THE PRIME RECORDED AFTER THE CARTRIDGE ALARM. A ZERO BASAL RATE WAS RECORDED AT 12:11 DUE TO LOSS OF PRIME WARNING. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING ACCURATELY/NO LOSS OF PRIME WARNINGS WERE DUPLICATED. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING THE CORRECT FORCE. NO INSULIN DELIVERY DEFECTS WERE FOUND. THE 68 UNIT PRIME EMPTIED CARTRIDGE. THE ZERO BASAL RATE WAS DUE TO LOSS OF PRIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORT CONTACTED ANIMAS ON BEHALF OF HER SON (THE PATIENT) REPORTING THAT HE WAS TAKEN TO A HOSPITAL WITH A BLOOD GLUCOSE (BG) OF 29 MG/DL. THE PATIENT'S FATHER CONTACTED ANIMAS ON (B)(6) 2011 AND PROVIDED ADDITIONAL INFORMATION. THE REPORTER INDICATED THAT THE INSULIN CARTRIDGE WAS OBSERVED TO BE EMPTY BY THE SCHOOL NURSE WHEN IT WAS REMOVED FROM THE PUMP. FURTHER INVESTIGATION REVEALED THAT 68 UNITS WAS REPORTEDLY PRIMED PRIOR TO THE PATIENT SUFFERING THE INJURY. THE ANIMAS REP INVOLVED IN THIS CONTACT DETERMINED THAT THE PATIENT POSSIBLY PRIMED 68 UNITS WHILE ATTACHED. HOWEVER, THE REP WAS UNABLE TO CONFIRM THE SEQUENCE OF EVENTS IN THE PUMP'S HISTORY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTERS CLAIMED THAT THE PATIENT WAS TAKEN TO A HOSPITAL WITH A BG LEVEL OF LESS THAN 40 MG/DL.

    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 8 YR Hospitalization| L