BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3406722 · Received October 11, 2013

    Report

    Report Number
    2531779-2013-17409
    Event Type
    Injury
    Date Received
    October 11, 2013
    Report Date
    September 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 04/29/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/18/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX STARTED ON 03/23/2016. DUE TO CONTINUOUS USE OF THE PUMP, THE HISTORIES AND BLACK BOX DATA FOR THE EVENT HAVE BEEN OVERWRITTEN. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. 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 PATIENT¿S FATHER CONTACTED ANIMAS TO REPORT THAT THE PATIENT WAS OBTAINING HIGH BLOOD GLUCOSE (BG) READINGS. THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) WHEN SHE WENT TO BED ON THE EVENING OF (B)(6) 2013 WAS 171 MG/DL, WHICH WAS NORMAL FOR THE PATIENT. AT APPROXIMATELY 1:20AM ON (B)(6) 2013, THE PATIENT WOKE UP NOT FEELING WELL WITH A BG OF 418 MG/DL. AT 3:41AM THE PATIENT¿S BG WAS UP TO 445 MG/DL AND THE PATIENT HAD SYMPTOMS OF VOMITING, ABDOMINAL PAIN AND TESTED POSITIVE FOR MODERATE KETONES. THE REPORTER STATED THEY DELIVERED RECOMMENDED BOLUS AMOUNTS; HOWEVER, PATIENT¿S BG REMAINED ELEVATED. AT 5:40AM, THEY CHANGED OUT THE PATIENT¿S SITE/SET/CARTRIDGE AND CONTINUED TO DELIVER BOLUSES USING PUMP UNTIL 6:45AM WHEN THE PUMP WAS DISCONTINUED. ONCE PUMP TAKEN OFF, THE HIGH BGS TREATED WITH INJECTIONS. AT 11AM THE PATIENT¿S BG WAS AT 325 MG/DL AND SHE WAS PUT BACK ON THE PUMP. THE REPORTER STATED BY 3:28PM THAT AFTERNOON, THE PATIENT¿S BG WAS 391 MG/DL AND BY 3:55PM IT WENT UP TO 425 MG/DL. THE PATIENT WAS TAKEN OFF THE PUMP AGAIN AND ON BACK UP PLAN. THE PATIENT¿S FATHER STATED THAT THE PATIENT ADMINISTERED NOVOLOG INJECTIONS AT 4PM AND AGAIN AT 7PM. AT 6:03PM, THE PATIENT¿S BG HAD GONE DOWN TO 49 MG/DL WITH SYMPTOMS OF SHAKY, LETHARGIC AND LEGS SORE. THE PATIENT ATE SUPPER AT TIME OF LOW BG AND HER BG CAME BACK UP TO 150 MG/DL. AT THE TIME OF TROUBLESHOOTING, THE REPORTER CONFIRMED THE PUMP WAS SET TO THE CORRECT DATE AND TIME AND ALL ADVANCED PUMP SETTINGS WERE PROGRAMMED AS INTENDED. THERE WERE NO ASSOCIATED ALARMS IN PUMP HISTORY. THE PATIENT¿S FATHER CONFIRMED BASAL SETTINGS WERE CORRECT. IT WAS NOTED THAT ALL BOLUSES WERE DELIVERED APPROPRIATELY AND TOTAL DAILY DOSE (TDD) WAS ACCURATE WHEN COMPARING TO BASAL AND BOLUS HISTORY AND SETTINGS. THE REPORTER DENIED ANY ISSUES WITH INFUSION SET OR SITE. AFTER REVIEWING THE PUMP, THE ANIMAS REPRESENTATIVE INFORMED THE PATIENT¿S FATHER THERE WAS NO INDICATION OF A PUMP MALFUNCTION. THE REPORTER WAS ADVISED TO DISCUSS BG ISSUES WITH HCP. ALTHOUGH REVIEW OF THE PUMP DID NOT REVEAL A PUMP MALFUNCTION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522101 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R