BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2961392 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01771
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: A REVIEW OF THE PUMP'S USER SETTINGS SHOW THE INSULIN ON BOARD (IOB) DURATION WAS SET TO ¿ON¿ WITH 3.0 HRS DURATION. A TEST WAS PERFORMED WITH 10U BOLUS AND A DURATION PERIOD OF 3.0 HRS. IMMEDIATELY AFTER THE BOLUS WAS PERFORMED THE 10U WAS CORRECTLY DISPLAYED ON THE IOB STATUS SCREEN. AFTER THE 3 HRS THE IOB STATUS WAS 0.00U AND THIS WAS ACCURATELY REFLECTED ON THE IOB STATUS SCREEN. THE IOB WAS FOUND TO FUNCTIONING PROPERLY. A CRACK AT CASE SEAL OF BATTERY COMPARTMENT WAS OBSERVED; THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. 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 FOR EVALUATION. 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. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE INSULIN ON BOARD (IOB) IS NOT CALCULATING CORRECTLY ON THE PUMP. THE REPORTER STATED THAT ON (B)(6) 2013, AT 2:18 PM, THE PATIENT'S BLOOD GLUCOSE (BG) WAS 110MG/DL. THE PATIENT ATE 15 GRAMS OF CARBOHYDRATES, THERE WAS NO INSULIN ON BOARD SO THE PUMP RECOMMENDED 0.65 UNITS OF INSULIN AS A CORRECTION. THE PATIENT THEN CHECKED AGAIN AT 3:00 PM, THE PATIENT'S BG WAS 73 MG/DL AND SHE WAS GIVEN 10 GRAMS OF CARBOHYDRATES. BEFORE THEY BOLUSED THE IOB WAS NOW 0.73 UNITS. THE REPORTER WAS UNSURE HOW THE INSULIN ON BOARD INCREASED WITHOUT GIVING ANY MORE INSULIN. THE REPORTER ALSO STATED THAT THE DAY BEFORE THE PT CHECKED HER BG AT 11 AM AND THE BG WAS 99MG/DL, SHE WAS EATING 15 GRAMS OF CARBOHYDRATES, AND THE IOB WAS AT .54 UNITS. THE REPORTER STATED THAT THE PUMP DID NOT SUBTRACT THE INSULIN ON BOARD. CUSTOMER SUPPORT EXPLAINED TO THE REPORTER THAT IF THE PATIENT IS IN TARGET OR ABOVE RANGE THE PUMP WILL NOT SUBTRACT THE IOB BECAUSE THE IOB IS BEING USED FOR A PREVIOUS CORRECTION AND NOT FOR THE CURRENT CARBOHYDRATES BEING EATEN SO IT WILL NOT BE SUBTRACTED. THE REPORTER AGREED WITH THE EXPLANATION. THE REPORTER STATED THAT THEY WILL CALL BACK WITH THE PUMP TO TROUBLESHOOT THE FIRST ISSUE. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HISTORY SETTINGS/IOB ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64653 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR