BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091770 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03488
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP EMITTED A (B)(4) ALARM DURING AN EZ PRIME OPERATION. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON THE FORCE SENSOR AND ON THE DRIVE ASSEMBLY GEARS. THE PUMP MOTOR WAS TESTED AND FOUND TO BE OPERATIONAL. THE GEAR ASSEMBLY WAS FOUND TO BE SEIZED. FURTHER INVESTIGATION INTO THE NO CARTRIDGE DETECTED COMPLAINT WAS UNABLE TO BE COMPLETED DUE TO THE SEIZED DRIVE ASSEMBLY. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND THERE WAS EVIDENCE OF MOISTURE INSIDE THE BATTERY COMPARTMENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE PUMP EMPTIED THE CARTRIDGE OF INSULIN DURING THE LOAD STEP AFTER PUTTING IN A NEW CARTRIDGE. THE PATIENT REPORTED THAT THE PUMP HAS BEEN EXPOSED TO WATER, AND THAT THERE IS A CRACK IN THE CASE. HE STATED THAT THERE IS CORROSION IN THE BATTERY COMPARTMENT, BUT NO MOISTURE EVIDENT IN THE CARTRIDGE COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE INSULIN WAS ALLEGEDLY DISPENSED DURING THE LOAD STEP.

    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 45 YR