BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2090338 · Received May 16, 2011

    Report

    Report Number
    2531779-2011-03445
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): NO DEFECT IN INSULIN DELIVERY WAS FOUND. DAILY INSULIN DELIVERY TOTALS REFLECT PROGRAMMED BASAL RATES. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HIGH BLOOD GLUCOSE LEVELS DUE TO CONTINUED USE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. BLACK BOX REVEALS PUMP RETURNING TO DEFAULT TIME AND DATE FOLLOWING A POWER ON RESET. AFTER SETTING DATE AND TIME ON PUMP BATTERY WAS REMOVED. PUMP WAS LEFT WITHOUT POWER FOR 1 HOUR; WHEN PUMP WAS POWERED ON IT HAD RETURNED TO DEFAULT TIME AND DATE. PUMP WAS OPENED AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE REPORTER REPORTED THE PATIENT OBTAINED TWO ELEVATED BLOOD GLUCOSE READINGS AFTER SHE CHANGED THE INFUSION SITE. EARLIER THAT DAY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 201 MG/DL. AFTER THE PATIENT CHANGED THE INFUSION SITE, SHE OBTAINED THE BLOOD GLUCOSE READINGS OF 262 MG/DL AND 270 MG/DL. AT THAT TIME THE PATIENT EXPERIENCED THE SYMPTOMS OF NAUSEA AND FEELING ILL; SHE DID NOT CHECK FOR URINARY KETONES. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PATIENT WAS ADVISED TO CHANGE THE INFUSION SITE, CHECK HER BLOOD GLUCOSE LEVEL AND TAKE A BOLUS DOSE OF INSULIN. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PUMP SETTINGS WERE CORRECT, THE PUMP DATE/TIME WAS CORRECT, THE TOTAL BASAL AND BOLUS DOSES CORRECTLY MATCHED THOSE PROGRAMMED, THERE WERE NO ISSUES WITH THE INFUSION SITE, AND NO LEAKS, AIR BUBBLES OR KINKS WERE SEEN IN THE CANNULA. THERE IS NO EVIDENCE THE PUMP WAS NOT FUNCTIONING APPROPRIATELY IN ACCURATELY DELIVERING INSULIN. HOWEVER, AS THE PATIENT OBTAINED MULTIPLE ELEVATED BLOOD GLUCOSE READINGS AND EXPERIENCED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R