BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2160680 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04904
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND DURING TESTING. UNABLE TO ADEQUATELY INVESTIGATE THE COMPLAINT AS NO METER WAS RETURNED AND PUMP HISTORIES HAVE BEEN OVERWRITTEN. THE PUMP WAS EXERCISED FOR 24HRS WITH NO DIFFICULTIES. THE PUMP/METER PAIRED WITH NO PROBLEMS; A 1.55U BOLUS WAS PERFORMED FROM THE METER WITH NO COMMUNICATION ERROR BEING DUPLICATED. A 1.5U BOLUS WAS ALSO PERFORMED FROM THE PUMP WITH NO PROBLEMS. CURRENT BLACK BOX DATA SHOWS TYPICAL USAGE ALARMS AND WARNINGS; NO METER WAS RETURNED WITH THE PUMP SO A TEST METER WAS USED FOR TESTING. A REVIEW OF THE BLACK BOX AND PUMP HISTORIES SHOWS PUMP WAS USED AFTER THE ORIGINAL COMPLAINT DATE OF (B)(4) 2011. ALL BLACK BOX AND PUMP HISTORIES HAVE BEEN OVERWRITTEN. AN "EZPRIME" OPERATION WAS PERFORMED WITH NO DIFFICULTIES NOTED; UNITS REMAINING WERE CORRECTLY CALCULATED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED SETTINGS ISSUE WITH THE ANIMAS PUMP. THE PATIENT ALLEGED THAT THERE IS A DIFFERENCE OF 0.05 UNIT OF INSULIN BETWEEN THE ONETOUCH PING METER AND THE ANIMAS PUMP WHEN THE SAME BLOOD GLUCOSE RESULT IS ENTERED FOR BOTH DEVICES. WHEN THE PATIENT ENTERED THE BLOOD GLUCOSE RESULT FROM THE METER, THE METER SETTING RECOMMENDS 1.55 UNITS OF BOLUS INSULIN TO CORRECT HIS BLOOD GLUCOSE. WHEN THE PATIENT ENTERED THE SAME BLOOD GLUCOSE FROM THE ANIMAS PUMP, THE ANIMAS PUMP ALLEGEDLY RECOMMENDS 1.50 UNITS. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONFIRMED THAT THE DATE AND TIME SET CORRECTLY. THERE WAS NO PRODUCT MISUSE. THE PATIENT WAS ADVISED TO MONITOR THE DISCREPANCY AND CALL BACK IF THE ISSUE PERSISTS. THE PUMP WILL NOT BE RETURNED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE ISSUE.

    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 33 YR