BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2241520 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06682
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 CONCLUSIONS CAN BE MADE AT THIS TIME.

    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: THE DATA FROM THE TIME OF THE REPORTED INCIDENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT THE PUMP WAS DELIVERING INSULIN ACCURATELY UP TO THE DATE THE PUMP WAS LAST USED. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT WITH EVIDENCE OF MOISTURE DAMAGE AND A BATTERY COMPARTMENT LEAK. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNSPECIFIED DATE AT 1:00 AM, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 60 MG/DL. THE PATIENT CONSUMED TWO GLUCOSE TABLETS AND WENT TO BED. AT 2:00 AM, SHE WOKE UP EXPERIENCING THE SYMPTOM OF DISORIENTATION, AND HER BLOOD GLUCOSE LEVEL WAS 30 MG/DL. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOUR GLUCOSE TABLETS AND ORANGE JUICE. HER BLOOD GLUCOSE LEVEL WAS 400 MG/DL 1.5 HOURS AFTERWARDS. THE PATIENT DID NOT SEEK MEDICAL ATTENTION OR TREATMENT. IT WAS REPORTED, THE PATIENT HAD INCREASED HER BASAL RATE BY 0.200 UNITS PER 24 HOURS THE DAY PRIOR DUE TO HER MENSES AND ATTENDING A CONFERENCE AND DANCE. TROUBLESHOOTING REVEALED THE PUMP SETTINGS WERE CORRECT, THE DATE/TIME WAS CORRECT, THE BASAL SETTING WAS CORRECT, ALL BASAL/BOLUS TOTAL DOSES DELIVERED CORRECTLY MATCHED THOSE PROGRAMMED. THERE IS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN. THE PATIENT CHANGED HER BASAL RATE AND SUBSEQUENTLY SUFFERED BLOOD GLUCOSE READINGS AND SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA, AND RECEIVED TREATMENT WITH GLUCOSE. 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 39 YR Life Threatening| R