BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5903499 · Received August 25, 2016

    Report

    Report Number
    2531779-2016-22871
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Report Date
    August 19, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 01/31/2017-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/11/2017: THE BOLUS HISTORY SHOWS A FULLY DELIVERED 8.80U COMBO BOLUS ON EVENT DATE (B)(6) 2016 AT 09:11. A FULLY DELIVERED 8.80U COMBO BOLUS (B)(6) 2016 AT 07:22. PRIOR TO THE EVENT DATE, THE BOLUS HISTORY SHOWS CANCELLED COMBO BOLUS ON (B)(6) 2016 19:05 WHERE 6.07U OF A PROGRAMMED 6.6U WAS DELIVERED. THE AVAILABLE BB SHOWS A FULLY DELIVERED 8.80U COMBO BOLUS ON (B)(6) 2016 AT 08:17 AND A FULLY DELIVERED 8.80U COMBO BOLUS ON 2016-08-18 AT 19:12. THE BB SHOWS 5.00U DELIVERED OF A PROGRAMMED 10.0U EZBG NORMAL BOLUS DUE TO EAW-175 -PARTIAL DELIVERY USER ABORTED (PUMP) WARNING ON (B)(6) 2016 19:42. THEN ON (B)(6) 2016 19:43 A 10.0U COMBO BOLUS WAS PROGRAMMED AND FULLY DELIVERED. AN UNEXPLAINED LOSS OF PRIME WAS RECORDED ON (B)(6) 2016 12:49; DELIVERIES NEVER RESUMED. EAW-164- EXCEEDS REMAINING INSULIN WARNING WAS RECORDED (B)(6) 2016 08:08; DELIVERIES RESUMED AT 08:10. A 1.0U COMBO BOLUS WAS MANUALLY PROGRAMMED IN THE PUMP FOR TESTING PURPOSES; THE COMBO BOLUS WAS FULLY DELIVERED WITH NO INTERRUPTIONS. NO HYPERTENSIVE OR STUCK KEYS WERE OBSERVED ON THE KEYPAD. COMBO BOLUS FEATURES WAS FOUND TO BE FUNCTIONING PROPERLY. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. NO DELIVERY INTERRUPTIONS OR EAW¿S OCCURRED DURING THE INVESTIGATION. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. DISPLAY SCREEN HAS A PINKISH CONTRAST. BATTERY COMPARTMENT IS CRACKED BELOW THE BUMPER PAD. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING AN OTHER (UNUSUAL) ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 21.7MMOL/L WITH POLYDIPSIA. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THE REPORTED BG EXCURSION DOES NOT MEET THE ANIMAS CRITERIA FOR A SERIOUS ADVERSE EVENT. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND THE PATIENT STATED THAT WHEN THEY USE THE COMBO BOLUS FEATURE THEY EXPERIENCED HIGH BGS. THIS REPORT IS BEING MADE DUE TO AN ALLEGED PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556645 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR