BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3050880 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-04018
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX SHOWED MULTIPLE "NO CARTRIDGE DETECTED" WARNINGS. THE PUMP FAILED TO DETECT THE CARTRIDGE DURING THE LOAD CARTRIDGE PHASE. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND FOUND THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THE PUMP WAS OPENED AND CONTAMINATION WAS OBSERVED IN THE FORCE SENSOR ASSEMBLY. THE FORCE SENSOR CIRCUIT WAS FOUND TO HAVE A CRACKED SOLDER CONNECTION AT THE FORCE SENSOR PINS. UNRELATED TO THE FORCE SENSOR ISSUE, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. ALSO UNRELATED TO THE ISSUE, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP DID NOT RECOGNIZE THE CARTRIDGE WHEN LOADED. THE PATIENT STATED THAT WHEN THE PUMP IS LOADED THE MOTOR DID NOT STOP AND CONTINUED TO SPIN UNTIL INSULIN WAS EXPELLED FROM THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149964 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR