BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2151910 · Received July 7, 2011

    Report

    Report Number
    2531779-2011-04738
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE TOTAL DAILY DOSE HISTORY WAS REVIEWED FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN PUMP OR ALARM HISTORY. THE PUMP BOOTED UP TO THE 'VERIFY' SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARM WARNINGS. THE PUMP WAS UNABLE TO COMPLETE THE REWIND STEP; A "MOTOR TIMEOUT ERROR - REWIND" OCCURRED. THE PUMP WAS OPENED FOR FURTHER ANALYSIS AND A MECHANICAL MOTOR ASSEMBLY FAULT WAS OBSERVED. THE INVESTIGATION OF THE PUMP COULD NOT BE THOROUGHLY BE COMPLETED DUE TO THE METER TIMEOUT ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND INDICATED THAT SHE SET UP HER SUPPLIES ON (B)(6) AND HER BLOOD GLUCOSE (BG) LEVELS WERE WITHIN NORMAL LIMITS. THE PATIENT CLAIMED THAT WHEN SHE WOKE UP HER BG'S WERE HIGH (UNKNOWN VALUES). AS THE DAY WENT ON, THE PATIENT CLAIMED THAT SHE BECAME MORE ILL. THE PATIENT MENTIONED THAT SHE HAD CRAMPS AND A SORE THROAT. THE PATIENT ALSO CLAIMED THAT SHE BEGAN TO VOMIT AND HER MOTHER BROUGHT HER TO AN EMERGENCY ROOM (ER) ON (B)(6) 2011. THE PATIENT WAS ADMITTED FOR DKA AND HER BG WAS "HI". SHE WAS TREATED WITH AN IV DRIP. ON (B)(6) 2011, THE PATIENT STATED THAT SHE WAS DISCHARGED FROM THE HOSPITAL AND CLAIMED THAT THE PUMP WAS NOW NOT WORKING. SHE ALSO MENTIONED THAT THE PUMP WAS ACTING "FUNNY" LATELY. ON AN UNSPECIFIED DATE/TIME DURING THE TIME OF CONCERN, THE PATIENT CLAIMED THAT THE PUMP STATED THAT THERE WERE ONLY 2 UNITS LEFT; HOWEVER, WHEN THE PATIENT PULLED OUT THE CARTRIDGE FROM THE PUMP, SHE CLAIMED THAT THERE WAS ABOUT 100 UNITS LEFT IN THE CARTRIDGE. WHEN THE PATIENT ATTEMPTED TO REWIND THE PUMP, SHE CLAIMED THAT THE PUMP KEPT REWINDING, SAYING THAT 300+ UNITS, AND ALARMED. THE PATIENT ALSO CLAIMED THAT HER BG'S WERE HIGH ALL DAY AND SHE WAS CORRECTING VIA SYRINGES. AT THE TIME OF THE CALL WITH ANIMAS, HER BG WAS REPORTEDLY "280 MG/DL." THE PATIENT WAS UNABLE TO COMPLETE TROUBLESHOOTING WITH THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT SINCE SHE WAS NOT FEELING WELL AT THE TIME. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP WAS ACTING "FUNNY" LATELY AND SHE WAS HOSPITALIZED FOR DKA. IT IS UNCLEAR AS TO WHAT PUMP ISSUES (IF ANY) THE PATIENT HAD PRIOR TO DEVELOPING DKA AND BEING HOSPITALIZED.

    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 14 YR Hospitalization| L| R