BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2871495 · Received December 13, 2012

    Report

    Report Number
    2531779-2012-14517
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 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. LAST BASAL DELIVERY WAS ON (B)(6) 2012 AT 1:08PM. A BASAL DELIVERY INTERRUPTION IS RECORDED ON (B)(6) 2012 AT 1:08PM AS A RESULT OF EN UNACKNOWLEDGED "144" WARNING FOR 12 HOURS. ON (B)(6) 2012 NO DELIVERIES WERE PERFORMED AS A RESULT OF A PERSISTENT CS 070 "MOTOR REWIND TOLERANCE ERROR" RECORDED SEVERAL TIMES IN THE BLACK BOX ON THE REPORTED FAILURE DATE. TDD ADD UP CORRECTLY AND REFLECT USER'S PROGRAMMED BASAL RATES TARGETS. THE PUMP POWERS UP NORMALLY AND PRIMES CORRECTLY. THE PUMP WAS EXERCISED FOR 24H. NO MOTOR OR ANY ALARMS OCCURRED DURING TESTING; 29H FLOW ACCURACY TEST WAS PERFORMED SUCCESSFULLY ON THE PUMP. HE PUMP WAS FOUND TO BE ABLE TO DELIVER WITHIN THE REQUIREMENT. MOTOR ALARMS WAS REPRODUCED, THE PUMP GAVE THE APPROPRIATE AUDIBLE AND VISIBLE ALERT. THE PUMP WAS OPENED AND MOTOR FLEX/CONNECTOR WAS FOUND INTACT WITH NO EVIDENCE OF DISLODGING. THE MOTOR DRIVE WAS TESTED WITH NO DEFECTS OBSERVED. THE PISTON CAP WAS REMOVED; THE O-RING WAS FOUND INTACT AND SECURELY ATTACHED TO THE LEAD SCREW. NO MOISTURE INGRESS OR INTERMITTENT CONDITION WAS FOUND WITH THE PCB.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING A BLOOD GLUCOSE OF 625 MG/DL WITH FREQUENT URINATION. THE PATIENT REPORTED THAT THE PUMP MOTOR WAS STALLING AND SOUNDED LIKE IT WANTED TO START BUT WAS NOT MOVING AT ALL. THE PATIENT REPORTEDLY TRIED REMOVING THE CARTRIDGE AND PERFORMING A REWIND STEP BUT THE PISTON WAS NOT MOVING. THE PATIENT REPORTED THAT BECAUSE OF THE MOTOR NOT MOVING, IT WAS BELIEVED THAT THE PUMP WAS NOT DELIVERING INSULIN. THE PATIENT REPORTED TREATING THE ELEVATED BLOOD GLUCOSE LEVELS WITH AN INSULIN INJECTION AND DISCONTINUED USE OF THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING INSULIN.

    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 18 YR Life Threatening