BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3893032 · Received June 24, 2014

    Report

    Report Number
    2531779-2014-18170
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: TESTING WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. THE PUMP HISTORY SHOWS THE LAST BOLUS AND THE LAST BASAL WERE DELIVERED ON (B)(6) 2014. PUMP HISTORY SHOWS NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. PUMP WAS EXERCISED FOR 24HR DURATION PERIOD WITH A 2.0U/HR BASAL RATE; AT CONCLUSION OF TESTING THE TDD BASAL HISTORY CORRECTLY REFLECTED 48.0U. PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED AT THE THREADS; RETURNED BATTERY CAP USED TO COMPLETE ALL TESTING. 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 HAD A BLOOD GLUCOSE (BG) BETWEEN 250 AND 500 MG/DL, WITH POLYDIPSIA AND EXCESSIVE SWEATING. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID NOT MATCH THE ACTIVE BASAL PROGRAM TOTALS, AND FOUND NO KNOWN CAUSE FOR VARIATION. BASAL HISTORY DOES MATCH THE ACTIVE BASAL PROGRAM SETTINGS. THE HEALTH CARE PROVIDER ADJUSTED THE BASAL RATE AND BOLUS SETTINGS. THE PATIENT WAS ADVISED TO GO TO AN ALTERNATE DELIVERY PLAN UNTIL THE REPLACEMENT PUMP ARRIVES. THE BG EXCURSION IS NOT BEING REPORTED AS IT DOES NOT MEET ANIMAS CRITERIA FOR A REPORTABLE ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED AS THE TOTAL DAILY DOSE INCONSISTENCY WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367624 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening