BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1901328 · Received November 13, 2010

    Report

    Report Number
    2531779-2010-02306
    Event Type
    Injury
    Date Received
    November 13, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 13, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. THE ANIMAS CDE INVOLVED WITH THIS CONTACT INDICATED THAT THE PATIENT WAS CONTINUING TO USE THE PUMP. 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO DATA IN THE BLACK BOX OR DOWNLOAD HISTORY FROM THE TIME OF THE REPORTED HOSPITALIZATION DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT AND HIS WIFE CONTACTED ANIMAS ALLEGING THAT SHE WAS ADMITTED TO A HOSPITAL FOR ELEVATED BLOOD GLUCOSE LEVELS AND TREATED WITH IV INSULIN. THE PATIENT CLAIMED THAT HE PERFORMED AN INSERTION SITE CHANGE ON (B)(6), 2010, AND WENT TO BED WITH NORMAL BLOOD GLUCOSE. THE PATIENT CLAIMED THAT HE WOKE UP THE NEXT MORNING VOMITING AND WITH A BLOOD GLUCOSE LEVEL OF 552 MG/DL AT 1:00 PM. HE RETESTED AT 2:00 PM AND SEVERAL TIMES UNTIL 5:00 PM AND GOT "HI" EACH TIME. THE PATIENT WAS ADMITTED TO A HOSPITAL WITH A BLOOD GLUCOSE LEVEL OF 656 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R