BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2120337 · Received June 10, 2011

    Report

    Report Number
    2531779-2011-04065
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS. 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. THIS REPORT IS MADE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO DATA WAS IN THE BLACK BOX OR DOWNLOAD HISTORIES FROM THE TIME OF THE REPORTED BGS DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED AN INTERNAL BATTERY FAILURE; THE TIME AND DATE DEFAULTED TO FACTOR SETTINGS IN PUMP HISTORY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED ERRATIC BLOOD GLUCOSE (BG) LEVELS. THE PATIENT INDICATED THAT SHE HAD AN ELEVATED BG LEVEL OF "490 MG/DL" THE PREVIOUS NIGHT. THAT SAME NIGHT, THE PATIENT CHANGED THE SITE AND BY BEDTIME, HER BG REPORTEDLY DROPPED TO "49 MG/DL." THE PATIENT'S HUSBAND TREATED HER WITH SUGAR PILLS AND ORANGE JUICE. THE PATIENT DENIED HAVING ANY SYMPTOMS OF NAUSEA, VOMITING, SHORTNESS OF BREATH, OR CHEST/ABDOMINAL PAIN. WHEN THE PATIENT WOKE UP, HER BG LEVEL WAS "467 MG/DL." THROUGH TROUBLESHOOTING, THE PATIENT'S HUSBAND OBSERVED AIR BUBBLES IN THE CARTRIDGE AND TUBING. THE PATIENT ADMITTED TO USING REFRIGERATED INSULIN ON THE NIGHT OF THE EVENT. THE PATIENT'S SITE HAD NO SIGNS OF REDNESS, IRRITATION, A BUMP, OR LEAKAGE. THE PATIENT DENIED THAT THE CANNULA WAS BENT WHEN THE SITE WAS CHANGED THE PREVIOUS NIGHT. THE PATIENT DENIED THAT THERE WAS BLOOD IN THE SET. NO ASSOCIATED ALARMS IN THE HISTORY WERE NOTED. ALL BOLUSES WERE GIVEN AS PROGRAMMED. ALL BASALS WERE DELIVERED AS PROGRAMMED. THE TDD ADDED UP CORRECTLY. THE I:C, ISF, AND TARGETS WERE ALL CORRECT IN THE PUMP. THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT WALKED THE PATIENT'S HUSBAND THROUGH PROGRAMMING A 5 UNIT BOLUS INTO THE AIR. THE PATIENT'S HUSBAND CONFIRMED SEEING 5 DROPS COMING OUT OF THE END OF THE TUBING. THE ANIMAS REPRESENTATIVE DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE REQUIRED ASSISTANCE/TREATMENT FROM HER HUSBAND AFTER HER BG LEVEL DROPPED TO "49 MG/DL." IT IS UNCLEAR HOWEVER AS TO WHAT ACTIONS THE PATIENT TOOK PRIOR TO SUFFERING THE HYPOGLYCEMIC EVENT.

    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 80 YR Life Threatening| R