BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3971054 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21952
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/09/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY WAS ON (B)(6) 2014 AND LAST BOLUS WAS A 1.00U BOLUS ON (B)(6) 2014. THE BLACK BOX SHOWS ON (B)(6) 2014 13:53 AN UNEXPLAINED POWER ON RESET EVENT; DELIVERIES RESUMED WHEN PUMP WAS PRIMED AT 14:59 (1HR 06MINS DELIVERIES INTERRUPTED). NO ASSOCIATED ALARMS NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE OBSERVED. THE TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECTS THE USERS PROGRAMMED BASAL RATE. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THERE WAS NO DEFECT FOUND. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT WAS HOSPITALIZED WITH A BLOOD GLUCOSE IN THE 500 MG/DL'S AND ABDOMINAL PAIN/VOMITING. THE HEALTH CARE PROVIDER IS REQUESTING A NEW PUMP. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) FOUND THAT THE PATIENT HAD AN UNSPECIFIED CONCURRENT ILLNESS. CS DID NOT IDENTIFY ANY POTENTIAL CAUSES OF THE PERCEIVED INACCURATE DELIVERY ISSUE, BUT THE PATIENT DISCONTINUED PUMP THERAPY BECAUSE OF AN ALLEGED INACCURATE DELIVERY ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP CANNOT BE RULED OUT AS CAUSING/CONTRIBUTING TO THE HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448210 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Hospitalization