BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2143387 · Received June 29, 2011

    Report

    Report Number
    2531779-2011-04550
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE DATA FROM THE TIME OF THE REPORTED INCIDENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE PUMP HISTORY SHOWED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2013. A REVIEW OF THE AVAILABLE 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE REPORTER, THE PATIENT'S MOTHER, REPORTED THAT ON AN UNSPECIFIED DATE IN (B)(6) 2011 THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 460 MG/DL AND SHE EXPERIENCED THE SYMPTOMS OF NAUSEA AND VOMITING. THE PATIENT'S MOTHER CHANGED THE INFUSION SITE AND CORRECTED THE PATIENT'S BLOOD GLUCOSE LEVEL USING THE PUMP. TWO HOURS LATER THE PATIENT'S BLOOD GLUCOSE LEVEL "RESPONDED". SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PUMP DATE/TIME WERE CORRECT, ALL SETTINGS WERE CORRECT, ALL BASAL/BOLUS TOTAL DOSES CORRECTLY MATCHED THOSE PROGRAMMED, NO INFUSION SITE ISSUES AND THERE WERE NO BENT CANNULAS. THERE WAS NO EVIDENCE THE PUMP WAS NOT ACCURATELY DELIVERING INSULIN. THE TECHNICAL SUPPORT REPRESENTATIVE ALSO DETERMINED THERE WAS A LARGE AIR BUBBLE IN THE INSULIN CARTRIDGE, AND THAT THE PATIENT'S MOTHER HAD BEEN USING REFRIGERATED INSULIN, WHICH CAN CAUSE AIR BUBBLES TO OCCUR. THE PATIENT'S TECHNIQUE WAS INCORRECT IN THAT REFRIGERATED INSULIN WAS USED AND THERE WERE AIR BUBBLES IN THE CARTRIDGE. THE PATIENT EXPERIENCED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA AFTERWARDS, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R