BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3253936 · Received July 30, 2013

    Report

    Report Number
    2531779-2013-12056
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX STARTS ON (B)(6) 2014. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(6) 2013 HAVE BEEN OVERWRITTEN. THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOWS NO EAW¿S ASSOCIATED WITH THE COMPLAINT. TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES. THE PUMP WAS TESTED ON A DELIVERY ACCURACY TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN THE REQUIRED SPECIFICATION. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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 LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT THAT SHE EXPERIENCED A BLOOD GLUCOSE READING OF 36 MG/DL AFTER SHE OVER EXERCISE THE DAY BEFORE AND DID NOT ADJUST HER INSULIN REGIMEN ACCORDINGLY. ACCORDING TO THE PATIENT, HER BLOOD GLUCOSE READING USUALLY DROPS AS IT DID THE DAY AFTER SHE PARTICIPATES IN EXTREME EXERCISE IF SHE DOES NOT ADJUST HIS INSULIN REGIMEN ACCORDINGLY. THE PATIENT WAS ABLE TO ADMINISTER SELF TREATMENT WITH JUICE AND RECHECKED HER BLOOD GLUCOSE READING AT 83 MG/DL. DURING TROUBLESHOOTING, THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION ASSOCIATED WITH THE REPORTED INCIDENT. THE BASAL SEGMENT AND ADVANCE SETTING WAS PROGRAMMED AS INTENDED. THE TIME/DATE WAS CORRECTLY SET. THERE WAS NO PRODUCT MISUSED. THIS COMPLAINT IS BEING REPORTED DUE TO A USE ERROR AS THE PATIENT DID NOT ADJUST HER INSULIN REGIMEN ACCORDING TO THE ACTIVITY SHE PARTICIPATED IN THE DAY BEFORE AND SUBSEQUENTLY EXPERIENCE HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355477 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening