BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2112085 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03883
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO INSULIN DELIVERY DEFECT WAS FOUND. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF THE REPORTED HIGH BLOOD GLUCOSE DUE TO CONTINUED USE. UNRELATED TO THIS COMPLAINT, THE TIME AND DATE DEFAULT TO THE MANUFACTURER'S SETTINGS AFTER POWER ON RESETS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT CONTACTED ANIMAS STATING THAT SHE WAS ADMITTED TO THE HOSPITAL WITH DKA ON MAY 3. AT THE TIME OF THE CALL SHE WAS REPORTEDLY ON AN IV DRIP AND WAS NOT ON PUMP THERAPY. SHE IS NOT SURE WHAT CAUSED HER ELEVATED BLOOD GLUCOSE UPON ADMISSION. THE NURSE AT THE HOSPITAL RESUMED THE PATIENT'S PUMP THERAPY IN THE HOSPITAL WHEN HER BLOOD GLUCOSE WAS AT TARGET BUT IT REPORTEDLY INCREASED AGAIN TO > 600 MG/DL. THE NURSE WAS USING A NON LUER INFUSION SET THAT IS NOT COMPATIBLE WITH THE PATIENT'S PUMP OR CARTRIDGE. THE PATIENT HAD REPORTEDLY BEEN ON THE PUMP FOR 2 MONTHS AND ONLY FOLLOWED UP WITH HER PRIMARY CARE PHYSICIAN ONLY ONCE. HER PRIMARY CARE PHYSICIAN SAID THE SETTINGS IN HER PUMP WERE ACCURATE. ALL BASAL AND BOLUS DOSES WERE DELIVERED ACCURATELY ACCORDING TO THE PUMP HISTORY. THE PATIENT'S INSULIN WAS NOT AVAILABLE FOR REVIEW. ALTHOUGH THERE IS NO REPORTED MALFUNCTION THIS COMPLAINT IS BEING REPORTED AS THE PATIENT WAS USING THE INCORRECT INFUSION SET, WHICH CAN CAUSE INACCURATE INSULIN DELIVERY AND CAN LEAD TO ELEVATED BLOOD GLUCOSE LEVELS AND DKA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R