BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3051425 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-04034
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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: THE PUMP¿S HISTORY SHOWED THAT THE LAST BASAL DELIVERY WAS ON 03/14/2013 AND THE LAST BOLUS DELIVERY WAS ON (B)(4) 2014. ON (B)(4) 2013, THERE WAS A LOSS OF PRIME WARNING RECORDED DUE TO A ROUTINE CARTRIDGE CHANGE AND IT WAS SHOWN TO BE CONFIRMED 18 TIMES; DELIVERIES THEN RESUMED. THE DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. ONLY TYPICAL USAGE WAS OBSERVED IN THE BLACK BOX AND ALARM HISTORY. A NORMAL BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. 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 FOR EVALUATION. 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 PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THEIR BLOOD GLUCOSE (BG) HAD BEEN RUNNING IN THE 500'S MG/DL (AT THE TIME OF THE CALL IT WAS 510 MG/DL) WITH KETONES, HEADACHE, MILD TO MODERATE INCREASED THIRST, FREQUENT URINATION, KETONES AND FEELING TIRED. THE PATIENT REMOVED THE PUMP FROM (B)(6) 2013 AND LEFT IT RUNNING. REVIEW WITH CUSTOMER SUPPORT (CS) REVEALED THAT ALL FOUR DAYS THE PUMP DELIVERED 25.2 UNITS OF BASAL. THE PATIENT REPORTED HE BOLUSED SEVERAL TIMES TODAY BUT THERE IS NO BOLUS HISTORY. CS REVIEWED THE SITE WITH THE PATIENT AND THERE WAS NO ABNORMALITIES, DENIED LEAKAGE AT THE SITE. THE PATIENT WAS ADAMANT IT IS THE PUMP AND NOT SCAR TISSUE. THE PATIENT DENIED BENT CANNULAS. THE PATIENT CONFIRMED THAT THEY WERE SICK. THE PATIENT GAVE INJECTION AND THE B COMES DOWN TO 100'S. THE PATIENT IS USING LEVEMIR AND NOVOLOG. A REVIEW OF THE PUMP INDICATES PUMP IS DELIVERING AS PROGRAMMED. THE PATIENT REPORTS HAS BOLUSED SEVERAL TIMES TODAY, BUT THERE IS NO BOLUS IN THE BOLUS HISTORY. BOLUS HISTORY START AT (B)(6) AND CALCULATES CORRECTLY WITH THE TOTAL DAILY DOSE. THE PATIENT CONFIRMS ALL SETTINGS ARE CORRECT, HAS NOT BEEN CHANGED IN A WHILE. THE PATIENT CALLED BACK AND STATED THAT THE HER BGS HAVE BEEN HIGH FOR PAST THREE DAYS. THE PATIENT HAS BEEN IN ALTERNATE INSULIN DELIVERY SINCE (B)(6) 2013. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THAT THE PATIENT EXPERIENCED DUE TO ALLEGATION OF A INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153500 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening