BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173511 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05166
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL INFORMATION: PATIENT OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS OMITTED IN ERROR ON THE 3500A.

    Additional Manufacturer Narrative · 1

    (B)(4):A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO AN UNRELATED TIME AND DATE ISSUE. THERE IS NO DATA FROM THE TIME OF THE REPORTED EVENT AVAILABLE DUE TO CONTINUED PUMP USE. DURING TESTING, IT WAS CONFIRMED THAT THE PUMP DISPLAYS THE APPROPRIATE WARNING TO DISCONNECT PRIOR TO PRIMING. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2011 IT WAS REPORTED THAT THE PATIENT PRIMED THE PUMP WHILE ATTACHED; THE PATIENT PRIMED 82 UNITS. THE PATIENT'S BLOOD GLUCOSE LEVEL AT THAT TIME WAS 483 MG/DL. THE PATIENT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT'S USUAL TOTAL DAILY DOSE IS 30 TO 35 UNITS INSULIN. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING THREE GLUCOSE TABLETS AND JUICE. THE PATIENT'S HUSBAND TOOK HER TO THE EMERGENCY ROOM. THERE IS NO EVIDENCE THE PUMP WAS NOT DELIVERING INSULIN ACCURATELY AND CORRECTLY. THE PATIENT'S TECHNIQUE WAS INCORRECT, AS SHE PRIMED THE PUMP WHILE STILL ATTACHED TO IT, AND INADVERTENTLY ADMINISTERED A LARGE DOSE OF INSULIN. 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 75 YR Life Threatening| R