BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2834537 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13676
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY INSULIN DELIVERY DOSE CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THERE ARE NO "PUMP NOT PRIMED" WARNINGS OR "CARTRIDGE DETECTED" WARNINGS OBSERVED IN THE BLACK BOX. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE. THERE WAS NO DEFECT FOUND. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY IS SCRATCHED DIM; THE LETTERS HAVE A RED HUE AND THE KEYPAD SYMBOLS WERE WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS REPORTING AN INCIDENT WHERE THE PUMP ALLEGEDLY INFUSED THE ENTIRE FULL CARTRIDGE OF INSULIN DURING THE LAST WEEK OF (B)(6) 2012. HER BLOOD GLUCOSE RESULTS WENT DOWN TO 32 MG/DL AND ANOTHER PERSON TREATED HER WITH A GLUCAGON INJECTION. SHE INDICATED SHE CONTINUED USE THE SAME PUMP AFTER THE INCIDENT AND HAD NO ISSUES SINCE THEN. THE PATIENT WAS UNABLE TO RECALL THE DETAILS REGARDING THE INCIDENT. SHE WAS UNSURE IF SHE PROGRAMMED THE BOLUS WRONG OR IF SHE WAS PRIMED WHILE ATTACHED TO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED A HYPOGLYCEMIC EVENT AFTER THE PUMP ALLEGEDLY INFUSED A FULL CARTRIDGE OF INSULIN. BASED ON THE PROVIDED INFORMATION, THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, USE ERROR CANNOT BE RULED OUT AS AN CONTRIBUTING FACTOR TO THE HYPOGLYCEMIC INCIDENT. THE PATIENT WAS ADVISED TO CONTACT ANIMAS RIGHT AWAY IN THE FUTURE FOR ANY INCIDENTS FOR IMMEDIATE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R