BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3192150 · Received June 27, 2013

    Report

    Report Number
    2183996-2013-01176
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 15, 2013
    Report Date
    July 30, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DELIVERY ACCURACY: THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE OCCLUSION LIMITS WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT ON (B)(6) 2013 AROUND 5:00PM THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 32.8 MMOL/L (590.4 MG/DL) AND SHE PROGRAMED A CORRECTION OF 10 UNITS OF INSULIN VIA THE INFUSION DEVICE. AT 6:00PM, HIS BLOOD GLUCOSE LEVEL WAS 37.7 MMOL/L (678.6 MG/DL). AFTER 7:00PM THE PATIENT CHANGED THE INFUSION SET, BOLUSED 8 UNITS OF INSULIN, AND ATE 3 BE. AT 8:00PM HER BLOOD GLUCOSE LEVEL WAS 30.8 MMOL/L (556.2 MG/DL). AFTER THE 8:00PM MEASUREMENT, SHE ADMINISTERED 10 UNITS OF INSULIN VIA INJECTION. SHE PROGRAMMED AN EXTENDED BOLUS OF 10 UNITS OF INSULIN FOR 2.5 HOURS AROUND 11:00PM TO 1:30AM THE NEXT DAY. ON (B)(6) 2013 AT 10:00AM, HER BLOOD GLUCOSE WAS 17.6 MMOL/L (316.8 MG/DL), SHE ATE 3 BE, AND ADMINISTERED 13 UNITS OF INSULIN VIA THE INFUSION DEVICE. SHE THEN CHANGED THE INSULIN CARTRIDGE AND INFUSION SET. AT 11:00AM, HER BLOOD GLUCOSE LEVEL WAS 30.8 MMOL/L (554.4 MG/DL) AND SHE ADMINISTERED 14 UNITS OF INSULIN VIA THE INFUSION DEVICE. AT 12:00PM, SHE ATE 3 BE AND ADMINISTERED 6 UNITS OF INSULIN VIA THE INFUSION DEVICE. AT 1:30PM, HER BLOOD GLUCOSE LEVEL WAS 8.3 MMOL/L (149.4 MG/DL). AT 3:00PM IT WAS 6 MMOL/L (108 MG/DL). AT 6:30PM IT WAS 4.3 MMOL/L (77.4 MG/DL), SHE ATE 3 BE, AND ADMINISTERED 4.5 UNITS OF INSULIN VIA THE INFUSION DEVICE. ON (B)(6) 2013 AT 9:00AM, HER BLOOD GLUCOSE LEVEL WAS 8.3 MMOL/L (149.4 MG/DL), SHE ATE 3 BE, AND ADMINISTERED 8 UNITS OF INSULIN VIA THE INFUSION DEVICE. AT 10:45, HER BLOOD GLUCOSE LEVEL WAS 19 MMOL/L (342 MG/DL). AT 11:00AM, SHE SPOKE WITH HER DIABETES SPECIALIST WHO SUGGESTED SHE GO TO THE HOSPITAL FOR STATIONARY TREATMENT. AT 12:19PM, HER BLOOD GLUCOSE LEVEL WAS 14.9 MMOL/L (268.2 MG/DL). THE PATIENT WENT TO THE HOSPITAL FOR STATIONARY TREATMENT. HER DIABETES SPECIALIST STATED THAT SHE DOES NOT THINK THE DEVICE DELIVERS AN ACCURATE AMOUNT OF INSULIN. THE INFUSION DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291797 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR Hospitalization HUMALOG