BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242575 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11705
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 10/02/2013 DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/10/2013WITH THE FOLLOWING FINDINGS:THE LAST BASAL AND BOLUS DELIVERY WAS RECORDED ON 09/10/2013. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS OR ERRORS RELATED TO THE REPORTED COMPLAINT FOUND IN THE BLACK BOX OR PUMP ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. 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. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING TESTING.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING BLOOD GLUCOSE (BG) ELEVATIONS UP TO 514 MG/DL WITHOUT SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA ON (B)(6) 2013. THE PATIENT REPORTED TREATING THE ELEVATED BG WITH HUMALOG VIA SYRINGE WHICH SUCCESSFULLY LOWERED THE BG TO 262 MG/DL. THE PATIENT REPORTED CHANGING THE SITE/SET/CARTRIDGE ON (B)(6) 2013 AT 7:30 PM WITHOUT CHECKING THE BG LEVEL. TWO HOURS AFTER THE SITE/SET/CARTRIDGE CHANGE, THE PATIENT REPORTED HER BG WAS 255 MG/DL. THE PATIENT REPORTED THAT WHEN SHE ATTEMPTED DELIVERY OF EZ-BOLUS WITH THE PUMP THE PUMP ALARMED FOR OCCLUSION AND CANCELLED THE BOLUS SEVERAL TIMES. THE PATIENT WAS ABLE TO DELIVER EZ-BOLUS ON A THIRD ATTEMPT. THIS INCIDENT REPEATED AGAIN A FEW HOURS LATER AND THE PATIENT WAS ABLE TO SUCCESSFULLY DELIVER A NORMAL BOLUS VIA THE PUMP ON THE SECOND ATTEMPT. THIS INCIDENT HAPPENED A THIRD TIME SEVERAL HOURS LATER AND AT THAT TIME, THE PATIENT CHANGED THE SITE/SET CARTRIDGE AND REPORTED HAVING NO FURTHER OCCLUSION ALARMS OR CANCELLED BOLUSES. THE PATIENT DENIED A BENT CANNULA OR INFUSION SITE NEAR SCAR TISSUE. THE PATIENT REPORTED THAT HER BG CONTINUED TO ELEVATE APPROXIMATELY SIX HOURS AFTER THE SITE/SET/CANNULA WAS CHANGED, GOING TO 455 MG/DL. THE PATIENT ALLEGED THAT THE PUMP WAS NOT DELIVERING PROPERLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PUMP MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343736 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR