BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3193358 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09142
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT SHE WAS HOSPITALIZED WITH ELEVATED BLOOD GLUCOSE READINGS OF ¿416, 525, AND 642 MG/DL.¿ THE PATIENT WAS DIAGNOSED WITH DKA AND HAD SYMPTOMS OF VOMITING AND SEVERE THIRST. THE PATIENT WAS TAKEN OFF OF PUMP THERAPY AND IS MANAGING HER DIABETES WITH INSULIN VIA SYRINGE. BASED ON THE CURRENT TROUBLESHOOTING, THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION. THE PATIENT DENIED ANY AIR IN THE INFUSION SET. THE PATIENT CHANGES THE INFUSION SET EVERY 3 DAYS. THE TROUBLESHOOTING WILL BE COMPLETED WHEN THE PATIENT CONTACTS ANIMAS BACK. THREE ATTEMPTS WERE MADE TO CONTACT THE PATIENT FOR FURTHER TROUBLESHOOTING. A LETTER WAS SENT TO THE PATIENT, REQUESTING A CALLBACK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD DKA AND WAS HOSPITALIZED WHILE ON INSULIN PUMP THERAPY. THE ANIMAS PRODUCT COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE REPORTED ISSUE. HENCE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292771 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R