BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3198514 · Received July 1, 2013

    Report

    Report Number
    2531779-2013-09299
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 8/7/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP SUCCESSFULLY COMPLETED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED RANGE. A REVIEW OF THE PUMP'S BLACK BOX SHOWED THE DATES IN THE TOTAL DAILY DOSE HISTORY WERE INCONGRUENT, CHANGING FROM (B)(6) 2013 AND FROM (B)(6) 2013. UNRELATED TO THE COMPLAINT, TESTING REVEALED THE TIME AND DATE RESET TO FACTORY SETTINGS. THE PUMP WAS OPENED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD WAS LEAKING. THE ISSUE OF INACCURATE DELIVERY OF INSULIN WAS NOT DUPLICATED 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 BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/09/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP'S BLACK BOX SHOWED THE DATES IN THE TOTAL DAILY DOSE HISTORY WERE INCONGRUENT, CHANGING FROM 02/11/2013 TO 02/10/2013 AND FROM 03/11/2013 TO 03/10/2013. DURING EVALUATION, A 29 HOUR FLOW ACCURACY TEST WAS SUCCESSFULLY PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, TESTING REVEALED THE TIME AND DATE RESET TO FACTORY SETTINGS. THE PUMP WAS OPENED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD WAS LEAKING. THE DAILY INSULIN DELIVERY TOTALS APPEAR TO BE INCONSISTENT DUE TO THE TIME AND DATE ISSUE. THE ISSUE OF INACCURATE DELIVERY OF INSULIN WAS NOT DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE ¿PUMP IS NOT GIVING 24 HOURS RATE REPORTS¿. THE PATIENT REPORTED AN ELEVATED BLOOD GLUCOSE (BG) THAT MORNING OF 356MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT INITIALLY STATED THAT SHE BOLUSED VIA THE PUMP TO CORRECT THE BG. THE PATIENT REPORTED RECEIVING AN ¿EXCEEDS LIMIT¿ ALERT; THE PATIENT¿S HEALTHCARE PROVIDER REPORTEDLY INCREASED THE LIMITS. CUSTOMER TECHNICAL SUPPORT ATTEMPTED TO REVIEW THE PUMP WITH THE PATIENT AND FOUND A 0UNIT BOLUS IN THE BOLUS HISTORY. THE PATIENT THEN STATED SHE GAVE AN INJECTION TO CORRECT BG. THE PUMP COULD NOT BE FURTHER REVIEWED AT THE TIME OF THE CALL WITH ANIMAS. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE IT IS UNCLEAR IF THERE WAS A DELIVERY ISSUE WITH THE PUMP OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300082 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR