BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2143261 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04540
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 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

    FOLLOW-UP #1 08/08/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEWED OF THE PUMP TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 SHOWED THAT DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    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 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 FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS SINCE SHE WAS CONCERNED ABOUT THE DELIVERY OF INSULIN FROM A PUMP. SHE ALSO REPORTED THAT HER BLOOD GLUCOSE (BG) HAD RISEN TO OVER "600 MG/DL" A DAY EARLIER. THE PATIENT CLAIMED THAT SHE HAD CHANGED HER SITES TWICE THE DAY BEFORE BUT HER ELEVATED BG LEVELS WERE ONLY RESOLVED WITH INJECTIONS. THE PATIENT MENTIONED THAT SHE HAD NAUSEA BUT DENIED HAVING SYMPTOMS OF VOMITING OR SHORTNESS OF BREATH. SHE ALSO DID NOT CHECK FOR KETONES. ON THE MORNING OF (B)(6) 2011, THE PATIENT CLAIMED THAT HER BG LEVEL WAS "120 MG/DL." AFTER BOLUSING FOR A MEAL WITH THE PUMP, THE PATIENT CLAIMED THAT HER BG LEVEL ROSE TO "261 MG/DL." THROUGH TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT DETERMINED THAT THE PUMP APPEARED TO BE DELIVERING ALL PROGRAMMED INSULIN. THE PATIENT DENIED OBSERVING ANY BENT NEEDLES, AIR BUBBLES, OR LEAKS. SHE ALSO DENIED OBSERVING ANY LUMPINESS OR HARDNESS AT THE SITES OR PROBLEMS WITH THE KEYPAD. THE ANIMAS REPRESENTATIVE ADVISED THE PATIENT TO USE A BACKUP PLAN FOR INSULIN DELIVERY SINCE SHE HAD LOST FAITH IN THE PUMP. THE PATIENT WAS ALSO ADVISED TO CONSULT WITH HER HEALTH CARE PROVIDER REGARDING RECOMMENDATIONS FOR SKIN SITE ROTATIONS DUE TO POSSIBLE ABSORPTION ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTED THAT THE PUMP HAD POSSIBLE INSULIN DELIVERY ISSUES AND HER BG LEVEL ROSE TO A LEVEL THAT MEETS ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    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 55 YR Life Threatening