BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2832466 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13612
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): 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. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED. THE PUMP PASSED A FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING INSULIN WITHIN THE REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) AND REPORTED LOW BLOOD GLUCOSE (BG) EPISODES. THE PATIENT INDICATED THAT FOR THE PREVIOUS 2 DAYS, SHE HAD GOTTEN LOW BG LEVELS DOWN INTO THE "40'S" MG/DL FROM 12:30-4:30 AM. DURING THE LOW BG EPISODES, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKINESS, WEAKNESS, AND SHORTNESS OF BREATH. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING ORANGE JUICE AND SUGAR. IN ONE INSTANCE, THE PATIENT WAITED 10 MINUTES AND THEN ATE A RICE CRISPY CAKE. THE PATIENT DENIED THAT SHE CHECKED HER BG LEVELS AFTER ADMINISTERING THE TREATMENT. SHE ALSO DID NOT REPORT HAVING THE NEED TO SEEK OR RECEIVE MEDICAL INTERVENTION DURING THE TIME OF CONCERN. THE PATIENT MENTIONED THAT SHE HAD CHANGED THE PUMP'S BATTERY 2 DAYS EARLIER AND AT THAT TIME, THE PUMP'S DATE/TIME HAD TO BE RESET. DURING TROUBLESHOOTING, THE PATIENT NOTICED THAT THE PUMP'S TIME OF DAY SETTING WAS INCORRECT. THE ANM REPRESENTATIVE INVOLVED IN THIS CONTACT WALKED THE PATIENT THROUGH CORRECTING THE PUMP'S TIME OF DAY SETTING FROM PM TO AM. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE SUFFERED LOW BG LEVELS WITH SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE PUMP AND/OR USE-ERROR CONTRIBUTED TO THE PATIENT'S INJURY. THE USER ALLEGED THAT THE PUMP SWITCHED TO DEFAULT DATE AND TIME AFTER A BATTERY CHANGE. THE PUMP DISPLAYS THE "VERIFY" SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE "VERIFY" SCREEN. THE ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. IT IS UNKNOWN IF THE PATIENT INCORRECTLY SET THE PUMP'S TIME OF DAY SETTING.

    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 62 YR Life Threatening