BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2989707 · Received March 5, 2013

    Report

    Report Number
    2531779-2013-02362
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BLACK BOX HISTORY WAS REVIEWED AND SHOWED THAT PRIOR TO A BATTERY CHANGE AT 8:25AM ON (B)(4) 2013, 76 UNITS OF INSULIN REMAINED; AFTER THE BATTERY CHANGE AND PRIMES TOTALING 7.08 UNITS; 43UNITS OF INSULIN REMAINED. THIS LEAVES APPROXIMATELY 26 UNITS OF INSULIN UNACCOUNTED FOR. NO BOLUSES WERE OBSERVED AT THE TIME OF THE INADVERTENT INFUSION. THERE ARE NO ¿PUMP NOT PRIMED¿ WARNINGS OR ¿NO CARTRIDGE DETECTED¿ WARNINGS OBSERVED IN THE BLACK BOX. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO A TIME AND DATE ISSUE. THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS. BEFORE PRIMING, THE PUMP DISPLAYED THE APPROPRIATE WARNING: ¿BE SURE SET IS DISCONNECTED FROM YOUR BODY. THEN SELECT CONTINUE.¿ A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR WAS WITHIN SPECIFICATIONS. THE REMAINING INSULIN WAS CALCULATED ACCURATELY DURING TESTING. A CARTRIDGE WITH 100 UNITS WAS CORRECTLY LOADED INTO THE PUMP. THE PUMP PASSED THE 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO PRIME ISSUES OCCURRED DURING TESTING. A LOSS OF PRIME WAS INDUCED AND THE PUMP GAVE THE APPROPRIATE VISUAL AND AUDIBLE ALERT. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY WERE RECORDED IN THE PUMP HISTORY. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT RECEIVED 40 UNINTENDED UNITS OF INSULIN AND EXPERIENCED BLOOD GLUCOSE (BG) AS LOW AS 40MG/DL AND WAS TREATED IN THE EMERGENCY ROOM (ER). THE REPORTER NOTED THAT THE MORNING OF (B)(6) 2013, THE PATIENT'S SITE, SET, AND CARTRIDGE WERE CHANGED AND THERE WERE 100 UNITS IN THE CARTRIDGE. THE PATIENT THEN REPORTEDLY WENT TO SCHOOL, AND AROUND 8:23AM THE REPORTER RECEIVED A CALL THAT THE PUMP HAD EMITTED A LOW BATTERY ALARM. THE REPORTER WENT TO THE SCHOOL TO CHANGE THE BATTERY, AND THE PATIENT STATED THAT HE FELT SOMETHING LIKE A BOLUS BEING DELIVERED. THE REPORTER CHECKED THE PUMP AND FOUND ONLY 60 UNITS OF INSULIN REMAINED IN THE CARTRIDGE. THE PATIENT'S BG WAS REPORTED TO BE 60MG/DL WITH DIZZINESS AT THE TIME THE ISSUE WAS NOTED, AND THEN DROPPED TO 44MG/DL. THE PATIENT WAS REPORTEDLY TAKEN TO THE ER WHERE HE WAS TREATED WITH IV DEXTROSE AND WAS REMOVED FROM THE PUMP. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE REPORTER AND FOUND NO UNINTENDED BOLUSES OR PRIMES IN THE PUMP HISTORIES. THERE WAS NO INDICATION ON TROUBLESHOOTING OF WHERE THE 40 UNITS OF INSULIN HAD GONE. CTS COULD NOT IDENTIFY A PUMP MALFUNCTION, HOWEVER THE PUMP WAS REPLACED SINCE THERE WAS NO EXPLANATION AS TO HOW OR WHY THERE WAS SEEMINGLY 40 UNITS OF INSULIN MISSING. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA REQUIRING MEDICAL INTERVENTION ASSOCIATED WITH A POTENTIAL PUMP DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94415 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R