BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851449 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14080
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: SEVERAL LOW AND REPLACE BATTERY WARNINGS WERE OBSERVED IN THE ALARM HISTORY. . A REVIEW OF THE TOTAL DAILY DOSE SHOWS THE PUMP WAS DELIVERING ACCURATELY UNTIL THE REPORTED EVENT DATE. VISUAL INSPECTION WAS PERFORMED AND THERE WAS NO PHYSICAL OR MOISTURE DAMAGE TO THE BATTERY COMPARTMENT OR BATTERY CAP. THE PUMP BOOTS UP NORMALLY WITH AUDITORY AND VIBRATORY ALARMS. AN EZPRIME WAS DONE WITH NO DIFFICULTIES. A REVIEW OF THE BLACK BOX SHOWS RAPID CURRENT DRAIN AND BATTERIES NOT LASTING AFTER A BATTERY CHANGE. THE PUMP WAS SET-UP FOR DURATION TESTING AND FLOW ACCURACY TESTING AND DURING TESTING, BATTERY WAS DRAINED AND PUMP HAD NO POWER. THE PUMP WAS OPENED AND A DEFECTIVE U33 WAS FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER, THE PATIENT'S MOTHER, CONTACTED ANIMAS TO REPORT A POWER ISSUE WITH THE REPORTED PUMP FOR TWO DAYS. DURING THE NIGHT, THE PUMP GAVE A "REPLACE BATTERY" ALARM, AND ON THE MORNING OF (B)(6) 2012 THE PATIENT WOKE UP WITH A BLOOD GLUCOSE LEVEL OF 508 MG/DL. ON THE MORNING OF (B)(6) 2012 THE PATIENT OBTAINED A READING OF 465 MG/DL AND HE TESTED POSITIVE FOR MODERATE KETONES. THE PATIENT DID NOT EXPERIENCE ANY OTHER SYMPTOMS. THE PATIENT WAS GIVEN A CORRECTING BOLUS DOSE OF 2.0 UNITS INSULIN VIA A SYRINGE INJECTION. TROUBLESHOOTING REVEALED THERE WAS NO DAMAGE OR CORROSION SEEN TO THE PUMP, IT HAD NOT BEEN EXPOSED TO MOISTURE OR TRAUMA, THE BATTERY CAP WAS SECURE AND TIGHT, AND THE BATTERY HAD BEEN REPLACED. THE ISSUE WAS NOT RESOLVED. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS AND SYMPTOMS SUGGESTING SEVERE INJURY AFTER THE PUMP POWER ISSUE OCCURRED, 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 4 YR Life Threatening| R