BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2103545 · Received May 26, 2011

    Report

    Report Number
    2531779-2011-03722
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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 CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO PUMP DATA FROM THE TIME OF THE EVENT WAS AVAILABLE DUE TO CONTINUED PATIENT USE. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2011 IT WAS REPORTED THE PATIENT OBTAINED MULTIPLE ELEVATED BLOOD GLUCOSE READINGS. ON (B)(6) 2011 AT 10:15 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 301 MG/DL. ON (B)(6) 2011 AT 1:15 AM HER BLOOD GLUCOSE READING WAS 486 MG/DL; AT 5:30 AM HER READING WAS "HI MG/DL" (GREATER THAN 600 MG/DL). AT THAT TIME THE PATIENT EXPERIENCED THE SYMPTOMS OF NAUSEA AND THIRST. THE PATIENT TOOK CORRECTION BOLUSES VIA A SYRINGE. ON THE EVENING OF (B)(6) 2011 THE PATIENT CHANGED THE INFUSION SITE AND FOUND THE CANNULA WAS BENT. THE PATIENT IS MANUALLY INSERTING THE CANNULA, AND HAD PROBLEMS WITH THE CANNULA BECOMING BENT. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PUMP'S SETTINGS WERE CORRECT, THE DATE/TIME WAS SET CORRECTLY, THE BASAL SETTINGS WERE CORRECT, ALL BASAL/BOLUS DOSES WERE CORRECT AND MATCHED THOSE PROGRAMMED AND THE PATIENT WAS CORRECTLY HANDLING THE INSULIN. NO LEAKS OR AIR BUBBLES WERE SEEN IN THE CANNULA OR INSULIN CARTRIDGE. THE CANNULA BECAME BENT WHEN THE PATIENT MANUALLY INSERTED THE INFUSION SET. THERE IS NO EVIDENCE THE PUMP WAS NOT ACCURATELY DELIVERING INSULIN. THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA WHILE USING THE PUMP; THEREFORE 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 20 YR Life Threatening