BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1972193 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00234
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO DATA AVAILABLE IN THE DOWNLOAD HISTORY OR BLACK BOX FOR THE TIME OF THE REPORTED BLOOD GLUCOSE EVENT ON (B)(4) 2012 DUE TO CONTINUED PATIENT USE. THERE WERE NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION RECORDED IN THE BLACK BOX OR ALARM HISTORY. THE TOTAL INSULIN DAILY DOSE CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THERE WAS NO DEFECT FOUND. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2010 EVENING, HE PT DISCOVERED A KINKED CANNULA SO HE CHANGED THE INFUSION SITE BUT HIS BLOOD GLUCOSE REMAINED "HIGH." THE PT WAS ONLY USING THE ABDOMEN AS THE INFUSION SITE. THE NEXT DAY, THE PT WAS TAKEN TO THE EMERGENCY ROOM. WHEN HE ARRIVED AT THE ER, HIS BG WAS IN THE 500S MG/DL. THE PT REPORTEDLY DID NOT HAVE ANY OTHER ILLNESS/INFECTION AT THE TIME OF THE REPORTED EVENT. THE PT WAS TAKEN OFF THE PUMP AND PUT ON INSULIN DRIP. ON (B)(6) 2010, THE PT RESUMED PUMP THERAPY IN THE HOSPITAL. THE PT'S BG CONTINUED TO BE HIGH IN THE 300-400 MG/DL RANGE SO THE DOCTOR CHANGED THE PUMP SETTINGS. THE PT'S BG RESULT AFTER THE PUMP SETTING CHANGE WAS NOT PROVIDED. THE ANIMAS REP REVIEWED THE PUMP WITH THE PT AND NOTED THE FOLLOWING: THE INSULIN WAS IN GOOD CONDITION, THERE WERE NO AIR BUBBLE ISSUES IN TUBING, NO ASSOCIATED ALARMS WERE FOUND IN THE PUMP'S HISTORY, AND ALL BOLUSES AND BASALS WERE DELIVERED AS PROGRAMMED. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY WAS HOSPITALIZED FOR 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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R