BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3865967 · Received June 11, 2014

    Report

    Report Number
    2531779-2014-16502
    Event Type
    Injury
    Date Received
    June 11, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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

    ADDTIONAL INFORMATION SUBMITTED 06/18/2014: ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AGAIN AND AT THAT TIME STATED THERE HAD BEEN NO ISSUE WITH THE ORIGINAL PUMP. THE HEALTH CARE PROVIDER TOLD THE PATIENT THERE HAD BEEN A UNSPECIFIED ISSUE WITH THE BOTTLE OF INSULIN IN USE AT THE TIME OF THE AE, BUT THE INSULIN WAS NOT EXPIRED. PATIENT CONTINUES TO USE ORIGINAL PUMP.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED 09/16/2015: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING RESULTS: THE BLACK BOX BEGINS ON (B)(4) 2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. DURING 24HR TESTING PUMP GIVE CS-064-0008 ALARM; 24HR TESTING COULD NOT BE COMPLETED DUE TO THE CS-064 ALARM. DURING A SECOND REWIND PUMP GIVES CS-078-0008 ALARM; TEST STEPS 17-20 AND 22 COULD NOT BE COMPLETED DUE TO THE CS-078 ALARM. UNABLE TO COMPLETE REQUIRED INVESTIGATION STEPS AND ADEQUATELY INVESTIGATE DUE TO MOISTURE IN PUMP. 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 AND ALLEGED AN INACCURATE DELIVERY ISSUE STARTE ON (B)(6) 2014. THE PATIENT HAD A BLOOD GLUCOSE (BG) 530 MG/DL, NO SYMPTOMS, AND WENT TO THE DOCTOR'S OFFICE TODAY. PATIENT WAS TREATED WITH INSULIN VIA INJECTION. THE PUMP IS BEING REPLACED. THIS ISSUE IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP COULD NOT BE ELIMINATED AS A CAUSE OF, OR CONTRIBUTOR TO, THE BG EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344529 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening