BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4051509 · Received September 2, 2014

    Report

    Report Number
    2531779-2014-24910
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/03/2014 WITH THE FOLLOWING FINDINGS: THE LAST BOLUS AND THE LAST BASAL DELIVERY WERE ON (B)(6) 2014. THE PUMP HISTORY SHOWED THAT THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2014 WITH NO DELIVERIES RESUMED. THE PUMP WAS ALSO MANUALLY SUSPENDED ON (B)(6) 2014 AND THEN DELIVERIES RESUMED ON (B)(6) 2014. THE PUMP HISTORY SHOWED NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPERGLYCEMIC EVENT ASSOCIATED WITH THE PUMP. THE REPORTER STATED THAT ON (B)(6) 2014, THE PATIENT WAS UNRESPONSIVE WITH BLOOD GLUCOSE (BG) GREATER THAN 500MG/DL AND WAS TREATED IN AN URGENT CARE FACILITY WITH UNSPECIFIED INTERVENTIONS. IT WAS REPORTED THAT THE PATIENT HAD DKA (DIABETIC KETOACIDOSIS) WITH UNSPECIFIED KETONES, EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION AND THAT PUMP USE WAS DISCONTINUED. AT THE TIME OF THE REPORT, NO INFORMATION WAS AVAILABLE REGARDING THE PUMP'S HISTORY AND SETTINGS OR ANY ADJUSTMENTS MADE BY THE PATIENT'S HEALTHCARE PROVIDER BEFORE OR AFTER THE ALLEGED EVENT. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED DKA DURING PUMP USE FOR WHICH A PUMP MALFUNCTION COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534749 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R