BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2881911 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14917
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 01/30/2013 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 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 DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY. BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. A 10 UNIT EZ-CARB AND A 10 UNIT EZ-BG BOLUS WERE PERFORMED SUCCESSFULLY AND ACCURATELY RECORDED IN THE PUMP HISTORY. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION.

    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 BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER CONTACTED ANIMAS TO REPORT THAT THE PATIENT'S HCP TOOK THE PATIENT OFF THE PUMP AND ADVISED HER TO CALL IN FOR A REPLACEMENT. THE PATIENT'S MOTHER STATED THAT THE PUMP'S HISTORY WAS NOT RECORDING SOME BOLUSES AND OTHER BOLUSES WERE RECORDING AS NORMAL WHEN THE PATIENT USED THE EZCARB AND/OR EZBG FEATURES. AT THE TIME OF THE CALL, THE REPORTER INFORMED CUSTOMER SUPPORT THAT PER THE PATIENT'S HCP HIS AVERAGE BLOOD GLUCOSE (BG) IS APPROXIMATELY 316 PER HIS A1C RESULT. THE REPORTER STATED THE PATIENT'S BG ON THE MORNING OF (B)(6) 2012, WAS 338 MG/DL AND WAS UP TO 400 MG/DL ON AN UNSPECIFIED DAY THE WEEK PRIOR. WITH THE ELEVATED BG READINGS, THE PATIENT COMPLAINED OF A SLIGHT HEADACHE. THE PATIENT'S MOTHER CONFIRMED THE PATIENT TESTED NEGATIVE FOR KETONES. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S MOTHER STATED THAT THE PUMP HISTORY WAS NOT SHOWING A BOLUS THE PATIENT HAD TAKEN EARLIER THAT MORNING OR THE EVENING PRIOR. CUSTOMER SUPPORT NOTED THAT A TRIAL BOLUS WAS DONE WITH THE REPORTER AT THE TIME OF THE CALL AND IT WAS NOTED THAT THE BOLUS CORRECTLY DISPLAYED IN THE BOLUS HISTORY AS EZCARB. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE ALLEGED PRODUCT ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED BG READINGS AND SYMPTOM DO NOT MEET ANIMAS' CRITERIA OF HYPERGLYCEMIA. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED HISTORY/SETTINGS ISSUE REMAINED UNRESOLVED AT THE TIME OF THE CALL.

    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