BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3102916 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06102
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(6) 2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/09/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA WAS FROM (B)(6) 2015. THE BLACK BOX AND PUMP HISTORIES FROM THE TIME OF THE ALLEGED EVENT WERE OVERWRITTEN DUE TO CONTINUED PUMP USE. A REVIEW OF THE AVAILABLE PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. A REVIEW OF THE CURRENT TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP MAINTAINED TIME ACCURATELY DURING THE 5 DAY DURATION TEST.

    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. 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 STATING THAT SHE EXPERIENCED A LOW BLOOD GLUCOSE (BG) OF 20MG/DL WHILE SLEEPING DUE TO INADVERTENTLY SWITCHING THE AM AND PM ON THE TIME SETTINGS. THE PATIENT DENIED THAT THE PUMP REVERTS TO DEFAULT TIME AND DATE WHEN CHANGING THE BATTERY, NOTING THAT WHEN SHE CHANGED THE BATTERY THE OTHER DAY SHE ACCIDENTALLY HIT A BUTTON ON THE VERIFY SCREEN AND CHANGED FROM AM TO PM. THE PATIENT STATED THAT HER HUSBAND NOTICED WHEN SHE HAD THE LOW BG AND TREATED WITH SODA. THE PATIENT REPORTEDLY DID NOT CONTACT HER HEALTHCARE PROVIDER FOR ASSISTANCE. THE PATIENT STATED HER BGS RESPONDED AND HER CURRENT BG WAS 118MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED SEVERE HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY AFTER MISTAKENLY SWITCHING THE TIME SETTINGS ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204586 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening