BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6973181 · Received October 24, 2017

    Report

    Report Number
    2531779-2017-24612
    Event Type
    Injury
    Date Received
    October 24, 2017
    Report Date
    October 1, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1: DATE OF SUBMISSION 18-JUN-2019. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 14-JUN-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THERE WERE CALL SERVICE 078-0008 ALARMS IN PUMP HISTORY. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP HISTORY SHOWED THE PUMP WAS DELIVERING PROGRAMMED BASAL RATE UNTIL ALARM OCCURS 2:36PM ON (B)(6) 2017. THE REWIND, LOAD AND PRIM STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. NO ALARMS OCCURRED DURING TESTING. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2017 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASURING 378 MG/DL AND EXTREME DROWSINESS, POLYURIA AND POLYDIPSIA FOUR HOURS AFTER DISCONTINUING INSULIN PUMP THERAPY DUE TO A PUMP ISSUE. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED A CALL SERVICE ALARM (078) ISSUE FOR MOTOR REWIND ERROR AFTER THE PUMP HAD GOTTEN WET. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH A CALL SERVICE ALARM/MOTOR REWIND ERROR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750982 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR