BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1924769 · Received December 6, 2010

    Report

    Report Number
    2531779-2010-02735
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    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 HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT'S MOM CONTACTED ANIMAS TO REPORT THE PT'S HOSPITALIZATION AND WANTED TO RULE OUT ANY PUMP MALFUNCTION. THE PT REPORTEDLY STARTED TO HAVE HIGH BLOOD GLUCOSE RESULTS (UNSPECIFIED RESULTS) ON (B)(6), 2010 AND THEN WENT TO THE EMERGENCY ROOM (ER) FOR DKA WITH TRACE OF KETONES LATER THE SAME DAY. THE PT WAS TREATED WITH IV INSULIN AND FLUIDS AND RELEASED LATER THE SAME AFTERNOON. THE NEXT DAY, THE PT BEGAN VOMITING AT 1 AM ON (B)(6), 2010 WITH HIGH BLOOD GLUCOSE LEVELS (UNSPECIFIED RESULT) AND WAS ADMITTED TO THE HOSPITAL. THE PT WAS TREATED WITH IV INSULIN AND FLUIDS AND RELEASED THE FOLLOWING NIGHT. THE ANIMAS REP WENT THROUGH TROUBLESHOOTING WITH THE PT'S MOM AND NOTED THE FOLLOWING: THE TOTALS IN THE HISTORY WERE CORRECT, THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY, AND THE PT'S MOM WAS BALE TO PRIME THE PUMP SUCCESSFULLY. ACCORDING TO THE PUMP HISTORY, THE LAST SITE CHANGE WAS ON (B)(6), 2010, WHICH WAS THE DAY BEFORE THE ER VISIT. THE PT'S MOM WAS UNABLE TO REPORT IF THERE WERE ANY SITE/SET ISSUES. THE ANIMAS REP REVIEWED THE BOLUS HISTORY AND NOTED THAT THE BOLUS AMOUNTS THAT RANGED FROM 0.35-1.55 UNITS THROUGHOUT THE DAY. THE PT'S MOM STATED THAT THE PT HAS A FEAR OF SEIZURES AND USUALLY DOES NOT GIVE HIMSELF ENOUGH BOLUS TO AVOID LOW BLOOD GLUCOSE LEVELS. THERE WAS NO INDICATION OF A PUMP MALFUNCTION; HOWEVER, THIS COMPLAINT IS STILL BEING REPORTED BECAUSE THE PT ALLEGEDLY WAS HOSPITALIZED WITH DKA.

    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 19 YR Hospitalization| L| R