BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982695 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00658
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PT'S MOM (REPORTER) CONTACTED ANIMAS TO REPORT THE PT'S ELEVATED BLOOD GLUCOSE LEVELS (BG). ON (B)(6) 2010, THE PUMP DISPLAYED 2 LOSS OF PRIME WARNINGS AND THE PT'S BG WAS 489 MG/DL WITH KETONES. THE PT WAS ALSO VOMITING. THE REPORTER INDICATED THAT THE CARTRIDGE CAP WAS LOOSE AND CONFIRMED THAT SHE WAS ABLE TO TIGHTEN AND SECURE THE CARTRIDGE CAP. THE INSERTION SITE WAS CHANGED AT THE TIME, A BOLUS WAS GIVEN, AND THE PT'S BLOOD GLUCOSE REPORTEDLY DECREASED BUT THE PT'S BLOOD GLUCOSE REMAINED IN THE 300-400 MG/DL RANGE WITH KETONES. THE INSERTION SITE AND CARTRIDGE WERE CHANGED 2 TIMES AND NEW INSULIN WAS USED. THE REPORTER STATED THAT THE INSERTION SITES ARE ROTATED BUT CONFIRMED THERE WAS SOME SCAR TISSUE. THE PT WAS USING INJECTIONS AND THE PUMP FOR CORRECTIONS. THE REPORTER WAS ALSO IN TOUCH WITH THE PT'S HEALTH CARE PROFESSIONAL ON (B)(6) 2011, AND THE BASAL RATES WERE ADJUSTED. ON (B)(6) 2011, THE PT'S MOTHER CALLED BACK TO REPORT AN "ABNORMAL MOTOR SOUND WHEN BOLUSING AND PRIMING, WHICH SHE FIRST NOTICED ON (B)(6) 2011 NIGHT. SHE INDICATED THAT SHE WAS ABLE TO OBTAIN A LOANER PUMP FROM THE DOCTOR'S OFFICE ON (B)(6) 2011, AND THE PT'S BG HAS GONE DOWN AFTER USING THE LOANER PUMP. A REPLACEMENT PUMP WAS SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED ELEVATED BG LEVEL WITH KETONES WITH THE SUBJECT PUMP. HER BG REPORTEDLY WENT DOWN AFTER USING A LOANER PUMP PROVIDED BY THE DOCTOR.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R