BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4013305 · Received August 15, 2014

    Report

    Report Number
    2531779-2014-23551
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: TESTING WAS UNABLE TO DUPLICATE REPORTED COMPLAINT. THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE ON (B)(6) 2014. AN UNEXPLAINED LOSS OF PRIME EVENT OCCURRED ON (B)(6) 2014 12:10; DELIVERIES NEVER RESUMED. PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2014 04:09 AND MANUALLY RESUMED AT 09:55. ON (B)(6) 2014 00:19 AND UNEXPLAINED LOSS OF PRIME OCCURRED; DELIVERIES RESUMED WHEN PUMP WAS PRIMED AT 01:12.. ON (B)(6) 2014 14:58 PUMP WAS MANUALLY SUSPENDED AND AT 16:01 PUMP WAS MANUALLY RESUMED. TYPICAL USAGE OBSERVED IN ALARM HISTORY. TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE..#4. PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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'S BLOOD GLUCOSE READ 'HIGH' ON THE METER, AND THERE WERE SYMPTOMS OF DEHYDRATION. PATIENT WAS TREATED WITH INSULIN INJECTIONS. REPORTER ALLEGED THAT THE PUMP DID NOT WORK AND THE HEALTH CARE PROVIDER HAS REQUESTED THAT THE PUMP BE REPLACED. THE INCIDENT OCCURRED WHILE THE PATIENT WAS HOSPITALIZED FOR A FRACTURED ANKLE, AND HOSPITAL STAFF WAS UNABLE TO MAKE THE PUMP WORK. THE FRACTURE OCCURRED WHEN THE PATIENT WAS AT HOME, WHILE ADDRESSING A DEXCOM WARNING OF BG GOING DOWN UNDER 100 MG/D: WENT TO THE RESTROOM, FELL, AND FRACTURED ANKLE. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP COULD NOT BE RULED OUT AS CAUSE/CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490451 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening