BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3020344 · Received March 25, 2013

    Report

    Report Number
    2531779-2013-03064
    Event Type
    Injury
    Date Received
    March 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/08/2013 - 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 TOTAL DAILY DOSE HISTORY WAS REVIEWED AND SHOWED TWO RECORDS FOR (B)(6) 2013 AND (B)(6) 2013. THE BLACK BOX SHOWED EVIDENCE OF A TIME AND DATE RESET AFTER REBOOTS ON (B)(6) 2013. THE DATE AND TIME WERE NEVER CORRECTED AND THE PUMP CONTINUED TO RUN ON THE DEFAULT SETTING OF (B)(6) 2007 00:00. THE PUMP SUCCESSFULLY COMPLETED AND PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM. THE BATTERY WAS REMOVED FOR 6 HOURS AND WHEN REPLACED, THE TIME AND DATE RESET TO FACTORY SETTINGS. THE PUMP WAS OPENED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD WAS LEAKING. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT PATIENT EXPERIENCED HIGH BLOOD GLUCOSE (BG) DURING THE DAY AND LOW BLOOD GLUCOSE (BG) AT NIGHT. THE PATIENT'S BG REPORTEDLY FLUCTUATED IN THE RANGE OF 40MG/DL TO 300MG/DL. THE PATIENT REPORTEDLY FELT SLUGGISH WHEN SHE WAS HIGH AND FELT SHAKY AND IRRITABLE WHEN SHE WAS LOW. THE PATIENT REPORTEDLY WAS TREATED VIA THE PUMP WHEN SHE WAS HIGH AND WAS GIVEN SUGAR TABLETS OR ORANGE JUICE TO TREAT THE LOW BG. THE PATIENT'S BG REPORTEDLY RETURNED BACK TO TARGET RANGE AFTER TREATMENT. IT WAS NOTED THAT THE PATIENT'S BG MEASUREMENT WAS TAKEN WITHIN 15 MINUTES AFTER TREATMENT. IT WAS NOTED THAT CUSTOMER SUPPORT (CS) RECEIVED A CALL FROM THE CLINICAL MANAGER (CM). THE CM STATED THAT WHEN THE PATIENT CAME IN FOR AN OFFICE VISIT, THE TIME AND DATE DEFAULTED TO FACTORY SETTINGS. THE CM STATED THAT PATIENT WAS HAVING ISSUES WITH HIGH AND LOW BGS DUE TO TIME AND DATE BEING OFF. IT WAS NOTED THAT THE ISSUE WITH THE TIME WAS CONFIRMED BY THE REPORTER. THE REPORTED HIGH BG WITH SYMPTOM DOES NOT MEET THE ANIMAS CRITERIA OF A HYPERGLYCEMIC EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGED TIME ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121463 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening