BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223073 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10470
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/11/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S TOTAL DAILY DOSE HISTORY SHOWED INCONGRUENT DATES, WITH DATE CHANGES FROM 04/26/2013 TO 01/01/2007, AND FROM 01/08/2007 TO 05/04/2013. THERE WAS NO DATA IN THE BLACK BOX FROM THESE DATE RANGES DUE TO CONTINUED PUMP USE. DAILY INSULIN DELIVERY TOTALS APPEARED INCONSISTENT DUE TO THE TIME AND DATE ISSUE. 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. 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

    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. DATE OF EVENT: NOT PROVIDED

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER, THE PATIENT¿S MOTHER, CONTACTED ANIMAS TO REPORT THE ONE TOUCH PING PUMP DATE/TIME SETTING REVERTED TO FACTORY DEFAULT SETTINGS AFTER A BATTERY REPLACEMENT. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED THE SYMPTOM OF SEIZURE. THE PATIENT¿S BLOOD GLUCOSE LEVEL RANGED FROM 20 MG/DL TO 30 MG/DL. THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION AND FELT BETTER AFTERWARDS; HE DID NOT SEEK ANY EMERGENCY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED DUE TO THE PUMP¿S TIME BEING INCORRECT THE PATIENT¿S BASAL RATE WAS BEING DISPENSED DURING THE NIGHTTIME HOURS. THE REPORTER WAS UNAWARE OF THE INCORRECT TIME SETTING. THE ISSUE WAS RESOLVED DURING TROUBLESHOOTING. THE PATIENT¿S TECHNIQUE WAS INCORRECT BY NOT RESETTING THE PUMP DATE/TIME TO THE CORRECT SETTINGS AFTER A BATTERY REPLACEMENT. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE INJURY AND RECEIVED TREATMENT WITH GLUCAGON AFTER THE PUMP ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322714 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R