BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3042126 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03817
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR ( THE PATIENT PROGRAMMING THE INCORRECT TIME AND DATE ON THE PUMP).

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: MANUAL TIME CHANGES WERE OBSERVED: ON FROM (B)(4) 2013 11:48PM TO (B)(4) 2013 12:48AM AND FROM (B)(4) 2013 10:46PM TO (B)(4) 2013 10:48PM. THE TOTAL DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TIME AND DATE CHANGES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A TIMEKEEPING ACCURACY TEST WAS PERFORMED; THE PUMP WAS KEEPING TIME ACCURATELY. UNRELATED TO THE COMPLAINT, THE DISPLAY LENS WAS FOUND TO BE SCRATCHED AND THE KEYPAD SYMBOLS WERE WORN.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT FOR THE PAST TWO WEEKS THE PATIENT HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE (BG) LEVELS. THE PATIENT WAS TREATED WITH GLUCAGON. THE REPORTER COULD NOT PROVIDE INFORMATION AROUND THE BG EVENT. THE REPORTER STATED THAT THE PATIENT HAD BEEN SELF ADJUSTING HIS BASAL RATES AND IS SEEING THE ENDOCRINOLOGIST IN A FEW DAYS. THE REPORTER STATED THAT THE PATIENT IS VERY ACTIVE IN SCHOOL, PLAYS SOCCER AND ON THE TRACK TEAM. THE REPORTER STATED THEY WILL CALL BACK WHEN THE HER SON (THE PATIENT) AND PUMP ARE AVAILABLE. THE REPORTER CALLED BACK ON (B)(6) 2013 STATING THAT THE LOW BG PROBLEM WAS A RESULT FROM WRONG TIME ON THE PUMP. THE AM AND PM WERE OFF. THE REPORTER STATED THAT THEY BELIEVED THAT THIS PATIENT ERROR CAUSED THE EVENT. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT THAT RESULTED FROM THE PATIENT PROGRAMMING THE INCORRECT TIME AND DATE ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146050 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening