BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3111008 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06325
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4): THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING INVESTIGATION. THERE WAS NO DEFECT FOUND. UNRELATED TO THE COMPLAINT, A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. REMOVED THE PUMP COVER AND REPLACED PINK DISPLAY WITH TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST WITH NO VISIBLE SIGNS OF DISCOLORATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE HAS BEEN HAVING ISSUES WITH ELEVATED BLOOD GLUCOSE (BG) FOR THE PAST THREE MONTHS. THE PATIENT REPORTED BGS BETWEEN 300MG/DL AND 600MG/DL, AND NOTED SYMPTOMS OF POLYURIA, DEHYDRATION, AND FEELING SLUGGISH. THE PATIENT HAS REPORTEDLY BEEN TREATED BGS WITH BOLUSES VIA THE PUMP. THE PATIENT STATED THAT SHE HAS DISCUSSED THE ISSUE WITH A NURSE PRACTITIONER, AND NO HEALTH ISSUES WERE FOUND THAT WOULD EXPLAIN THE REPORTED BG ISSUES. THE PATIENT'S HEALTHCARE PROVIDER REPORTEDLY TOLD THE PATIENT THAT THE ISSUES MAY BE DUE TO INFUSION SETS. THE PATIENT STATED SHE HAS BEEN TRAINED ON THE INFUSION SET THAT SHE IS USING AND HAS BEEN USING IF FOR TWO TO THREE YEARS. THE PATIENT STATED SHE ROTATES SITES AROUND HER STOMACH AND WAIST AREAS. THE PATIENT REPORTEDLY CHANGES SITES AND SETS EVERY TWO DAYS. THE PATIENT DENIED ANY TRAUMA OR DAMAGE TO THE PUMP AND DENIED ANY POWER LOSS. THE PATIENT STATED THAT THE NURSE PRACTITIONER REVIEWED HER BASAL RATES AND CONFIRMED THEY WERE CORRECT. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES ARE CORRECT; THERE WAS NO PUMP MALFUNCTION IDENTIFIED DURING TROUBLESHOOTING. ALTHOUGH THERE WAS NO PUMP DEFECT FOUND, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212441 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening