BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2900179 · Received January 7, 2013

    Report

    Report Number
    2531779-2013-00293
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 0/3/07/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY WAS ON (B)(6) 2013 THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE IS OBSERVED IN THE BLACK BOX/ALARM HISTORY. THE TOTAL DAILY DOSE ADDS UP AND EQUALS THE BASAL RATE TARGET. THE PUMP POWERS ¿ON,¿ PRIMES AND EXERCISED FOR 24 HOURS WITH NO ALARMS. FORCE SENSOR CALIBRATION READING IS ABOVE SPECIFICATIONS. THE PUMP PASSED DELIVERY ACCURACY TEST. THE FORCE SENSOR RESISTANCE IS WITHIN SPECIFICATIONS AT 7.2K OHMS THE PRODUCT PERFORMS WITHIN SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE PATIENT HAS EXPERIENCED TWO LOW BLOOD GLUCOSE LEVELS OF 33MG/DL AND 36MG/DL IN THE PAST THREE DAYS. THE PATIENT REPORTEDLY WOKE UP WITH CONFUSION AND SLURRED SPEECH. THE REPORTER INDICATED THAT THE PATIENT HAD TO GO TO THE EMERGENCY ROOM TO TREAT THEIR BLOOD GLUCOSE EXCURSIONS. THE PUMP WAS REVIEWED AND ALL SETTINGS WERE FOUND TO BE CORRECT. THE PATIENT IS NOT ON ANY NEW MEDICATIONS NOR ARE DO THEY HAVE ANY NEW ILLNESSES. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS WHICH REQUIRED MEDICAL INTERVENTION WHILE ON PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6518 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| L| R