BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033483 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03501
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/22/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON (B)(6) 2013. THE PUMP WAS USED AFTER THE ORIGINAL COMPLAINT DATE (B)(6) 2013 AND ALL HISTORIES AND BLACK BOX DATA FOR EVENT HAVE BEEN OVERWRITTEN. THE USERS PROGRAMMED BASAL RATES ARE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. THERE ARE NO ERRORS OR ALARMS RELATED WITH THE COMPLAINT IN THE CURRENT BLACK BOX OR ALARM HISTORY. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST. NO ALARMS OCCURRED DURING TESTING. PUMP FOUND TO BE OPERATING WITHIN REQUIRED RANGE. THE FORCE SENOR CALIBRATION CHECK IS OUT SPECIFICATIONS. A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING ISSUES WITH ERRATIC BLOOD GLUCOSE LEVELS. THE PATIENT INDICATED THAT BLOOD GLUCOSE LEVELS WENT AS HIGH AS 300 MG/DL WITH THIRST AND AS LOW AS 38 MG/DL WITH COLD SWEATS AND CONFUSION. THE PATIENT CONFIRMED THAT THERE WERE NO ALARMS ON THE PUMP AND NO INDICATION OF ANY INTERRUPTIONS IN THE INSULIN DELIVERY. THE PATIENT CONFIRMED THAT THERE WAS NO SIGN OF ILLNESS, NO CHANGES IN DIET, MEDICATION, OR ACTIVITY. THE PATIENT REPORTED THAT THE RATES WERE ADJUSTED BY A HEALTH CARE PROFESSIONAL AND BLOOD GLUCOSE LEVELS WERE WITHIN TARGET RANGE SINCE THE ADJUSTMENTS WERE MADE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED ERRATIC BLOOD GLUCOSE LEVELS RELATED TO A NEED FOR CHANGES TO THE BASAL INSULIN REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137282 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR