BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080821 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05388
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S BLACK BOX HISTORY WAS REVIEWED AND SHOWED THAT THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE ON (B)(4) 2013. THE DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; THE PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE ISSUE OF THE MOTOR SOUNDING SLOW WAS NOT ABLE TO BE DUPLICATED DURING THE INVESTIGATION AND THERE WAS NO DEFECT FOUND. 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.

    Additional Manufacturer Narrative · 1

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT EXPERIENCED A LOW BLOOD GLUCOSE OF 2.9 MMOL/L WHILE AT SCHOOL. THE REPORTER INDICATED THAT THE PATIENT WAS ABLE TO TREAT WITH ORAL CARBOHYDRATE. THE REPORTER INDICATED THAT THERE WAS AN ISSUE WITH THE MOTOR SOUNDING SLOW. THE REPORTER INDICATED THAT THERE WERE NO WARNINGS OR ALARMS REPORTED. THE PUMP WAS NOT AVAILABLE AT THE TIME OF THE EVENT TO TROUBLESHOOT. NO FURTHER INFORMATION WAS PROVIDED. THE REPORTED BLOOD GLUCOSE EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE INDICATION OF A PUMP INSULIN DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180831 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR