BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192349 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09070
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/10/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED THE PUMP WAS SUSPENDED ON (B)(6) 2013 AT 21:40, INSULIN DELIVERIES WERE NOT RESUMED. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. THE BASAL AND BOLUSES PRIOR TO THE EVENT ADDED UP APPROPRIATELY THE TOTAL DAILY DELIVERIES; THE PUMP WAS DELIVERING INSULIN ACCURATELY. THE PUMP SUCCESSFULLY PASSED A 29 HOUR FLOW ACCURACY TEST. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY. A TEST DISPLAY SCREEN WAS INSERTED AND FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF DISCOLORATION. THE ISSUE OF THE INACCURATE DELIVERY WAS NOT ABLE TO BE 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

    (B)(4). THE PUMP¿S SERIAL NUMBER WAS INADVERTENTLY SUBMITTED AS (B)(4). THE CORRECT SERIAL NUMBER IS (B)(4). THE DEVICE EVALUATION SUBMITTED ON 10/03/2013, WAS REPORTED ON THE CORRECT DEVICE. SUSPECT MEDICAL DEVICE SERIAL #: (B)(4).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON 06/21/2013 FOR A BLOOD GLUCOSE (BG) OF 33 MMOL/L. THE PATIENT WAS TAKEN OFF THE PUMP AND PLACED ON IV INSULIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. THE REPORTER STATED THAT THE PUMP WAS NOT AVAILABLE FOR REVIEW AND WAS ALREADY RETURNED TO ANIMAS. THE REPORTER STATED THAT THERE WERE NO ISSUES IN THE PUMP WITH BASAL RATES AND SETTINGS. THE REPORTER STATED THAT THE HEALTHCARE PROFESSIONAL FELT THAT THE PUMP WAS JUST NOT DELIVERING ACCURATELY. THE REPORTER STATED THAT THE PATIENT IS ON A REPLACEMENT PUMP AND BGS ARE BETWEEN 8 AND 10 MMOL/L. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292490 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization