BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091756 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03480
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # DATE OF SUBMISSION (B)(6) 2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE PUMP HISTORY. AN EZPRIME OPERATION WAS PERFORMED WITH NO ISSUES. DURING EVALUATION, TEST BOLUSES WERE SUCCESSFULLY PROGRAMMED AND DELIVERED, AND WERE CORRECTLY RECORDED IN THE PUMP HISTORY. THERE WERE NO INSULIN DELIVERY ISSUES FOUND ON INVESTIGATION. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    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

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD ON (B)(6) 2011 FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) BETWEEN 94 MG/DL AND 474 MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. A FAMILY MEMBER STATED THAT THE PATIENT TREATED HERSELF WITH INSULIN VIA THE PUMP AND SYRINGE; NO MEDICAL ATTENTION WAS REQUIRED. THIS BG DESCRIPTION DOES NOT MEET ANIMAS' CRITERIA FOR AN ADVERSE EVENT. AT THE SAME TIME, A FAMILY MEMBER REVIEWED THE PUMP WITH CUSTOMER SUPPORT AND DID NOT DISCOVER ANY EVIDENCE OF PRODUCT MALFUNCTION OR DEFECT. HOWEVER THE FAMILY MEMBER ALLEGED THAT THE PUMP WAS THE CAUSE OF THE PATIENT'S BG EXCURSIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE NON-SPECIFIC ALLEGATION OF PUMP MALFUNCTION.

    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 13 YR