BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2113080 · Received June 3, 2011

    Report

    Report Number
    2531779-2011-03901
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 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 07/21/2011. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(6) 2011 AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE ALARM HISTORY; THERE WERE NO ALARMS RELATED TO THE COMPLIANT RECORDED. THE BLACK BOX SHOWS THE FIRST BASAL DELIVERY WAS ON (B)(6) 2011 AT 10:03 AND THE LAST BASAL DELIVERY WAS ON (B)(6) 2011 AT 22:07.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE REPORTER REPORTED THAT ON (B)(6) 2011 AT 10:00 PM THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 38 MG/DL. AT THAT TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF CONFUSION, WEAKNESS AND HE FELT FAINT. PRIOR TO THIS READING, AT AN UNSPECIFIED TIME, THE PATIENT HAD OBTAINED A PRE-DINNER BLOOD GLUCOSE READING OF 153 MG/DL, AND HE HAD TAKEN A BOLUS DOSE OF INSULIN TO ACCOUNT FOR HIS DINNER. THE PATIENT CLAIMED HE ATE HIS ENTIRE DINNER MEAL. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE TABLETS AND ORANGE JUICE; HE DID NOT SEEK ANY MEDICAL ATTENTION. NO TROUBLESHOOTING COULD BE DONE, AS THE INSULIN PUMP WAS NOT AVAILABLE AT THE TIME OF THE CALL; THE PATIENT HAD RETURNED IT TO HIS PHYSICIAN. THE PATIENT NOTED HIS PHYSICIAN HAD JUST RECENTLY DECREASED HIS BASAL RATES; AND ALLEGED HIS PREVIOUS BASAL RATES MAY HAVE BEEN TOO HIGH. THE PUMP SETTINGS, TOTAL DAILY INSULIN DOSES DELIVERED AND CONDITION WERE UNKNOWN, AS THE PUMP WAS NOT AVAILABLE AT THE TIME OF THE CALL. THE PATIENT ALLEGEDLY BECAME SEVERELY HYPOGLYCEMIC AFTER TAKING A BOLUS DOSE OF INSULIN, AND RECEIVED TREATMENT WITH GLUCOSE AND FOOD TO ALLEVIATE HIS SYMPTOMS. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R