BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2771226 · Received October 3, 2012

    Report

    Report Number
    2531779-2012-11752
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. 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. A 2531779-03/24/2010/003-R.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ON TESTING, THE PUMP FAILED TO RECOGNIZE THE CARTRIDGE DURING THE LOAD STEP. THE FORCE SENSOR WAS TESTED AND FOUND TO BE OUT OF SPECIFICATION. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND REVEALED THE FORCE SENSOR FLEX WAS DAMAGED NEAR THE FORCE SENSOR PIN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) ALLEGING THAT THE PUMP DISPENSED INSULIN DURING THE LOAD STEP. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. DURING TROUBLESHOOTING, THE PATIENT REPRIMED. HOWEVER, SHE REPORTEDLY GOT A LOSS OF PRIME IMMEDIATELY. THE PATIENT THEN WENT THROUGH THE REWIND AND LOAD STEPS. THE PUMP SUCCESSFULLY COMPLETED THE REWIND. HOWEVER, DURING THE LOAD STEP, THE PUMP ALARMED THAT NO CARTRIDGE WAS DETECTED AND ALL THE INSULIN IN THE CARTRIDGE WAS PUSHED OUT. THE PATIENT WAS ADVISED TO DISCONTINUE USE OF THE PUMP. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD STEP. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. HOWEVER, THERE IS NO EVIDENCE THAT THE PUMP CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS, AND/OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    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 72 YR