BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1790087 · Received August 2, 2010

    Report

    Report Number
    2531779-2010-00857
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED AN EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. AROUND THE TIME OF DISCHARGE FROM THE EMERGENCY ROOM, THE PATIENT WAS AWAITING A NEW INFUSION SET BEFORE CHANGING HER INFUSION SITE. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE DATE OF THE REPORTED HOSPITALIZATION WAS (B)(6) 2010; THE PUMP HISTORIES INDICATE THAT THE PUMP WAS IN USE UNTIL (B)(6) 2011, THEREFORE THE HISTORIES FROM THE TIME OF THE REPORTED HOSPITALIZATION ARE UNAVAILABLE DUE TO CONTINUED PUMP USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT CURRENT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES AND NO ALARMS OBSERVED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A KEYPAD LEAK AND MOISTURE DAMAGE ON THE PCB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED AT THE EMERGENCY ROOM FOLLOWING LOSS OF CONSCIOUSNESS AND A SEIZURE.

    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 10 YR Hospitalization