BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3141253 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07470
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/05/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE DAILY INSULIN TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY RELATED TO THE COMPLAINT OBSERVED IN THE PUMP¿S 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. UNRELATED TO THE COMPLAINT, THE PUMP¿S HISTORY SHOWED EVIDENCE OF SHORT BATTERY LIFE. A HIGH CURRENT DRAW WAS MEASURED DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) /2013 ALLEGING LOW BLOOD GLUCOSE (BG) RANGING BETWEEN 42-90 MG/DL BEGINNING IN (B)(6) 2013 UP THROUGH THE PRIOR WEEK. THERE WERE NO SYMPTOMS OF HYPOGLYCEMIA REPORTED. THE REPORTED LOW BG LEVELS DO NOT MEET ANIMAS¿ CRITERIA OF A REPORTABLE ADVERSE EVENT. THE PATIENT FURTHER REPORTED ELEVATED BG THE WEEK OF THE CALL TO ANIMAS RANGING BETWEEN 310-415 MG/DL WITH SYMPTOMS OF NAUSEA AND SHORTNESS OF BREATH. THE PATIENT REPORTED BG AT THE TIME OF THE CALL TO ANIMAS WAS 351 MG/DL WITHOUT REPORTED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THE PATIENT REPORTED STARTING A NEW JOB WORKING IN A WAREHOUSE FROM 4:00 PM UNTIL 12:30 AM BEGINNING THREE WEEKS AGO. THE PATIENT REPORTED THAT HE DID NOT CHECK HIS BG LEVELS DURING THE FIRST WEEK OF EMPLOYMENT. DURING THE SECOND WEEK OF EMPLOYMENT, THE PATIENT REPORTED THAT HE TESTED HIS BG AND FOUND IT TO BE <70 MG/DL. THE PATIENT REPORTED SUCCESSFULLY TREATING THE HYPOGLYCEMIA WITHOUT ASSISTANCE WITH CONSUMPTION OF HARD CANDY OR GATORADE. THE PATIENT ALSO REPORTED FEELING ¿SWEATY¿ AT TIMES AND WOULD DRINK A BEER TO ELEVATE HIS BG AND WOULD THEN "FEEL BETTER". ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) ADVISED THE PATIENT THAT CONSUMPTION OF BEER CAN CAUSE BG TO DROP TOO LOW AND ADVISED THE PATIENT NOT TO DRINK ALCOHOL WHEN USING INSULIN. THE PATIENT REPORTED THAT WHEN HIS BG ELEVATES, HE ADMINISTERS A CORRECTION BOLUS VIA THE INSULIN PUMP. REVIEW OF THE PUMP BY ACTS REVEALED THE ADVANCED PUMP SETTINGS WERE TURNED ON, THE INSULIN-ON-BOARD (IOB) FUNCTION WAS TURNED OFF AND THE PATIENT WAS NOT USING EZ-BG OR EZ-CARB FUNCTIONS FOR BOLUS DELIVERIES. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT DID NOT ADMINISTER CORRECTION BOLUSES ON SEVERAL OCCASIONS FOR ELEVATED BG AND THAT THE PATIENT WAS MANUALLY PRIMING THE TUBING OF THE INFUSION SET RATHER THAN ALLOWING THE PUMP TO PRIME TO TUBING. THE PATIENT WAS ADVISED TO CONSULT HIS HEALTHCARE PROVIDER (HCP) FOR RECOMMENDATIONS ON USE OF THE IOB. THE PATIENT CONFIRMED CONSULTING WITH THE HCP AND STATED THAT THE HCP ORDERED THE IOB FUNCTION TO BE TURNED ON WITH 4-HOUR DURATION AND INSTRUCTED THE PATIENT TO CHECK HIS BG LEVELS MORE OFTEN. THE PATIENT CONFIRMED THAT HE HAD TURNED ON THE IOB FUNCTION AS INSTRUCTED BY THE HCP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG AS A RESULT OF INCORRECT USE OF THE INSULIN PUMP FOR INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243048 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR