BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1952109 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-02910
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO ANIMAS FOR EVAL. NO MECHANICAL ISSUES WERE OBSERVED THROUGH TROUBLESHOOTING.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY DID NOT CONTAIN DATA FROM THE DATE OF THE ALLEGED INCIDENT, (B)(4) 2012, DUE TO CONTINUED PATIENT USE. DATA WAS AVAILABLE FOR (B)(4) 2012 THRU (B)(4) 2012. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE RPTR CONTACTED ANIMAS ON (B)(6) 2010, ALLEGING HIGH BLOOD GLUCOSE LEVELS. THE RPTR CONTACTED ANIMAS ON BEHALF OF HER SON (THE PT). SINCE (B)(6) 2010, THE RPTR CLAIMED THAT THE PT'S BLOOD GLUCOSE LEVELS HAD BEEN AROUND 200-600 MG/DL. THE RPTR CLAIMED THAT A DOCTOR HAD THE PT COME OFF OF THE PUMP AND GO TO INJECTIONS. THE RPTR ALSO CLAIMED THAT THE PT'S BLOOD GLUCOSE LEVEL HAD COME DOWN TO THE 180 MG/DL RANGE. THE PT WAS REPORTEDLY CHANGING SITES EVERY 2-3 DAY. NO BENDING OR KINKING OF THE CANNULAS WERE OBSERVED. NO SIGNS OF INSULIN LEAKING WERE ALSO OBSERVED. THE RPTR DID NOT HAVE CARTRIDGE WITH THE PUMP FOR TROUBLESHOOTING. THE RPTR DENIED THAT THE PT HAD ANY RECENT ILLNESSES OR NEW MEDICATIONS. THE RPTR WAS ADVISED TO TRY USING AN INFUSION SET FROM A NEW BOX.

    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 11 YR Life Threatening