BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3033356 · Received April 3, 2013

    Report

    Report Number
    2183996-2013-00566
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE ALARM FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. INVESTIGATION UNIT (IU) RECEIVED ONE METER WITH SERIAL NUMBER (B)(4). THE RETURNED METER WAS TESTED USING RETENTION STRIPS, CODE KEY, CONTROLS, AND BATTERIES, AND ALL TESTING PRODUCED ACCEPTABLE RESULTS. NO MALFUNCTIONS WERE OBSERVED WITH THE RETURNED METER. THE ADAPTER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, MOTHER REPORTED THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO HIGH AND THIS HAS CAUSED SEVERE HYPOGLYCEMIA. PATIENT'S BLOOD GLUCOSE WAS 21 MG/DL ON (B)(6) 2013 AT 9:00 P.M. SHE WOULD NOT WAKE UP, AND HER MOTHER DELIVERED A GLUCAGON INJECTION. MOTHER REPORTED THIS HAS OCCURRED 4 TIMES IN THE PAST MONTH, AND THE PARAMEDICS WERE CALLED THE FIRST TIME. EACH TIME, HER BLOOD GLUCOSE WAS IN THE 20'S MG/DL AND SHE WAS TREATED WITH GLUCAGON. SHE STARTED USING THE INFUSION DEVICE IN (B)(6) 2013. SHE MET WITH A TRAINER WHO PROGRAMMED THE BASAL RATES, BUT THE TRAINER DID NOT KEEP THE FOLLOW-UP APPOINTMENT. SHE SAW A DIABETES EDUCATOR AND ENDOCRINOLOGIST ON THE DAY OF THE REPORT. THE DIABETES EDUCATOR FOUND THE BASAL RATES WERE SET TOO HIGH AT 38.0 UNITS PER DAY INSTEAD OF 21.7 UNITS. WHEN SHE SAW THE ENDOCRINOLOGIST, HE DISCONTINUED INFUSION DEVICE THERAPY AND ADVISED HER TO USE INSULIN INJECTIONS. THE INFUSION DEVICE, CARTRIDGE, INFUSION SET, ADAPTER, AND BLOOD GLUCOSE METER WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137196 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR Required Intervention NOVALOG