BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243201 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11755
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP HISTORY REVEALED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A REVIEW OF THE PUMP HISTORY REVEALED THAT THE TIME AND DATE HAD RESET TO FACTORY DEFAULT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD HAD FAILED. THE ISSUE OF INACCURATE DELIVERY WAS NOT DUPLICATED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE RANGE OF 288MG/DL TO OVER 600MG/DL. THE PATIENT REPORTEDLY HAD LARGE KETONES WHEN HER BG ELEVATED TO 593MG/DL AT 8AM AND THEN WAS VOMITING AT 10AM. THE PATIENT REPORTEDLY WAS TREATED VIA CORRECTION INJECTION. THE PATIENT REPORTEDLY HAD THE SITE/SET CHANGED AND THE ISSUE WAS NOT RESOLVED. THE REPORTER DENIED HAVING ISSUES WITH THE SITE/SET OR CARTRIDGE. IT WAS NOTED THAT THE PATIENT HAD MADE ADJUSTMENTS TO THE INSULIN TO CARBOHYDRATE RATIO (I:C) AT THE HEALTH CARE PROVIDER'S OFFICE (HCP) AND THE BASAL RATE WAS RECENTLY ADJUSTED BY THE HCP TWO WEEKS AGO. IT WAS NOTED DURING TROUBLESHOOTING, NO BOLUSES WERE PERFORMED ON (B)(6) 2013. A REVIEW OF THE PUMP HISTORY INDICATED MULTIPLE PRIME EVENTS AND A ¿LOW BATTERY¿ ALARM ON (B)(6) 2013. THE PATIENT REMAINED ON INSULIN INJECTIONS AND THE HEALTH CARE PROVIDER (HCP) REQUESTED PUMP TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION THERE MAY HAVE BEEN A DELIVERY ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342354 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening