BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2872140 · Received December 13, 2012

    Report

    Report Number
    2531779-2012-14533
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/22/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A "REPLACE BATTERY" ALARM WAS OBSERVED IN THE BLACK BOX ON (B)(6) 2012 AT 3:33 AND DELIVERIES WERE NOT RESUMED UNTIL 4:50. 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. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER, THE PATIENT'S MOTHER, CONTACTED ANIMAS TO REPORT THAT ON (B)(6) 2012 THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "GREATER THAN 600 MG/DL" AND SHE EXPERIENCED THE SYMPTOMS OF VOMITING AND LARGE AMOUNTS OF KETONES. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA AND WAS TREATED INTRAVENOUSLY WITH INSULIN. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE LEVELS RESPONDED TO INSULIN INJECTIONS AT 200 MG/DL. WHEN THE PATIENT RETURNED TO INSULIN PUMP THERAPY, HER BLOOD GLUCOSE LEVELS ROSE TO "IN THE 300'S MG/DL." TROUBLESHOOTING REVEALED ALL PUMP SETTINGS, PROGRAMMING AND DATE/TIME WERE CORRECT. IT WAS ALSO DETERMINED THE REPORTER'S TECHNIQUE OF INSERTING THE INFUSION SET WAS INCORRECT, AND THERE WAS A BENT CANNULA IN THE INFUSION SET, WHICH CAN LEAD TO UNDER-INFUSION OF INSULIN. THE PATIENT'S TECHNIQUE WAS INCORRECT BY HAVING BENT A CANNULA IN THE INFUSION SET. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA WHILE USING THE PUMP, AND WAS HOSPITALIZED AND TREATED FOR DKA, 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 12 YR Hospitalization| L