BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2231925 · Received September 1, 2011

    Report

    Report Number
    2531779-2011-06421
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE BLACK BOX VERIFIED THAT THE PUMP WAS RETURNING TO DEFAULT TIME AND DATE. THE TOTAL DAILY DOSE VALUES WERE INCONSISTENT DUE TO TIME AND DATE RESETTING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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. THE REPORT IS 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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED HE ALLEGED BECAME HYPOGLYCEMIC TWO DAYS AFTER HE CHANGED THE BATTERY ON THE ANIMAS PUMP ON (B)(6) 2011. REPORTEDLY, THE PATIENT DID NOT TAKE NOTICE TO MAKE SURE HIS DATE AND TIME WAS CORRECT AFTER THE ANIMAS PUMP PROMPTED THE PATIENT TO VERIFY THE DATE AND TIME. ON (B)(6) 2011, THE PATIENT AWOKE TO A BLOOD GLUCOSE READING OF 31 MG/DL AND WAS FEELING CONFUSED. HIS WIFE TREATED HIM WITH JUICE AT THE TIME OF CONCERN. HIS BLOOD GLUCOSE CAME UP LATER TO 98 MG/DL. AT 11:30 PM THAT DAY, THE PATIENT REALIZED THAT THE ANIMAS HAD THE INCORRECT DATE AND TIME. THE PATIENT ATTRIBUTED THE ALLEGED HYPOGLYCEMIA TO THE DIFFERENT BASAL RATES THROUGHOUT THE DAY AND THE INCORRECT DATE AND TIME. THE PATIENT INDICATED THAT THE DATE AND TIME RESET ISSUE NEVER OCCURRED BEFORE AND THAT HE WILL BE DILIGENT TO VERIFY THE DATE AND TIME WHEN PROMPTED. THIS COMPLAINT IS BEING REPORTED DUE TO USER ERROR AND BECAUSE THE PATIENT ALLEGEDLY HAD A BLOOD GLUCOSE READING OF 31 MG/DL AND RECEIVED TREATMENT AFTER THE DATE AND TIME RESET ISSUE BEGAN.

    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 70 YR Life Threatening| R