BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3150536 · Received June 6, 2013

    Report

    Report Number
    2531779-2013-07867
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/31/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP HISTORY REVEALED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES UP UNTIL THE LAST DATE USED; ONLY TYPICAL USAGE WAS OBSERVED IN THE ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, A REVIEW OF THE PUMP¿S BLACK BOX REVEALED THAT THE TIME AND DATE HAD RESET TO FACTORY DEFAULT ON 05/08/2013. THE PUMP WAS OPENED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD HAD FAILED. THE COMPLAINT COULD NOT 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING SHE EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 24MG/DL. THE PATIENT REPORTEDLY WAS DOZING AND JERKING AND WAS TAKEN TO THE HOSPITAL. THE LOW BG ISSUES REPORTEDLY CONTINUED TO OCCUR STARTING A WEEK AGO. THE PATIENT REPORTEDLY WAS TREATED AND RELEASED THE SAME DAY FROM THE HOSPITAL. IT WAS NOTED THAT THE PATIENT HAS BEEN HAVING ISSUES WITH LOW BGS AND THE HEATH CARE PROVIDER (HCP) HAS RECENTLY ADJUSTED THE PUMP¿S BASAL SETTING. THE PATIENT STATED AFTER THE PUMP'S SETTINGS WERE RECENTLY ADJUSTED BY THE HCP THERE WERE NO FURTHER ISSUES WITH LOW BGS. THE PATIENT DECLINED TO TROUBLESHOOT THE PUMP AND THE PATIENT WAS NOT IMPLICATING THE PUMP AS A CONTRIBUTING FACTOR. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. THE PATIENT'S BG ISSUES REPORTEDLY RESOLVED AFTER GETTING ASSISTANCE FROM THE HCP IN ADJUSTING THE PUMP'S SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249668 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R