BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2933069 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01285
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP'S HISTORY SHOWED THAT NO BOLUSES WERE PERFORMED ON THE EVENT DATE OF (B)(6) 2013 AND THAT THE PUMP WAS POWERED DOWN FOR 13 HOURS THAT DAY. A 0 UNIT BOLUS WAS PERFORMED AT 5:35 PM (B)(6) 2013. DURING EVALUATION, THE PUMP POWERED ON NORMALLY. THE PUMP WAS UNABLE TO DETECT THE CARTRIDGE DURING THE LOAD STEP. INVESTIGATION REVEALED THAT THE THERE WAS CONTAMINATION ON THE FORCE SENSOR PLATE AND THE FORCE SENSOR READING WAS OUT OF CALIBRATION. INVESTIGATION COULD NOT BE COMPLETED DUE TO THE FORCE SENSOR ISSUE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE PUMP HISTORY DID NOT SHOW BOLUS HISTORY FOR (B)(4) AS WELL AS THE TOTAL DAILY DOSE HISTORY. THE PATIENT STATED THAT THEY DEFINITELY GAVE HERSELF A BOLUS BUT THERE WERE NO BOLUSES RECORDED IN THE HISTORY. THERE WERE NO CANCELLED BOLUSES IN THE HISTORY EITHER. TROUBLESHOOTING INDICATED THAT THERE WERE NO ALARMS, DISCREPANCIES IN BASAL HISTORY, BOLUS AND TOTAL DAILY DOSE HISTORY CONFIRMS NO BOLUSES FOR THE SPECIFIED DATES. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39128 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR