BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210972 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09757
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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 AND EVALUATED BY PRODUCT ANALYSIS ON 09/11/2013 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE DISPLAY IS DIM; THE LETTERS HAVE A RED HUE. SETTING THE CONTRAST TO THE HIGHEST SETTING DID NOT IMPROVE THE DISPLAY. WHEN A TEST DISPLAY SCREEN WAS USED THE DISPLAY FUNCTIONED PROPERLY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT HAD A BLOOD GLUCOSE (BG) OF 48MG/DL LAST NIGHT WITH MODERATE THIRST. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PATIENT STATED THAT THEY DID NOT BOLUS BEFORE DINNER DUE TO NOT BEING ABLE TO SEE THE PUMP AND THEN FORGOT TO BOLUS WHEN SHE GOT HOME LAST NIGHT. THE PATIENT REPORTED THAT SHE THEN BOLUSED SO LATE AND DID NOT DO ANOTHER BG BEFORE BOLUSING. THE PATIENT STATED THAT THEY WOKE UP WITH A BG OF 57MG/DL THIS AM. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PATIENT TREATED WITH SIX GLUCOSE TABLETS. THE BG AT TIME OF CALL IS 70MG/DL. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE DISPLAY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309739 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR