BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1962577 · Received January 7, 2011

    Report

    Report Number
    2531779-2011-00097
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 12, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT'S PARENTS CONTACTED ANIMAS ON HIS BEHALF ALLEGING THAT HE HAS HAD HIGH BLOOD GLUCOSE LEVELS (UP TO 300 MG/DL) FOR 1 WEEK. THE RPTRS CLAIMED THAT THE PT BLOOD GLUCOSE WAS NOT RESPONDING TO CORRECTIONS VIA THE PUMP. HOWEVER, THE RPTRS CLAIMED THAT THE PT'S BLOOD GLUCOSE LEVELS WOULD DECREASE VIA SYRINGE. AT THE TIME OF THE CONTACT WITH ANIMAS, THE RPTRS INDICATED THAT THE PT'S BLOOD GLUCOSE LEVEL WAS AT 190 MG/DL, AN HR AFTER CORRECTION VIA SYRINGE. THE PT WAS REPORTEDLY USING HIS ABDOMEN FOR INSERTION AND WAS ROTATING SITES. THE SITES WERE REPORTEDLY FREE OF SCAR TISSUE AND SIGNS OF INFECTION. NO LEAKAGE WAS FOUND AT THE SITES. THE CANNULA WAS REPORTEDLY NOT BENT OR KINKED. THE RPTRS DENIED THAT THERE WAS A CARTRIDGE LEAK OR AIR IN THE CARTRIDGE. THE PUMP'S DATE/TIME WAS CORRECT. THE BOLUS HISTORY SHOWED ALL COMPLETED WITHIN THE PAST 24 HRS. THE BASAL RATES WERE VERIFIED AS BEING CORRECT. THE TDD ADDED UP CORRECTLY. THE LUER LOCK AND CARTRIDGE CAP WERE OBSERVED TO BE SECURE. NO BLOOD OR KINKS WERE FOUND IN THE TUBING. THE RPTRS DENIED ANY CHANGE IN ACTIVITY OR DIET. THE RPTRS ALSO DENIED ANY ILLNESS OR NEW MEDICATIONS. ALTHOUGH THERE IS NO EVIDENCE THAT THERE WAS A MECHANICAL PROBLEM WITH THE PUMP DURING TROUBLESHOOTING, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE RPTRS CLAIMED THAT THE PT WAS NOT RESPONDING TO CORRECTIONS VIA THE PUMP AND DEVELOPED TRACE KETONES.

    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 Life Threatening