BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 2980885 · Received February 27, 2013

    Report

    Report Number
    2183996-2013-00256
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 9, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFULLY AND NO MALFUNCTION COULD BE OBSERVED DURING THE TECHNICAL INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE REFERENCE INFUSION SET SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD FOR LOT #223541 WAS VERIFIED AND FOUND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED HER BLOOD GLUCOSE HAS BEEN ABOVE 200 MG/DL SINCE (B)(6) 2013, AND SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. SHE SWITCHED TO THE BACKUP INFUSION DEVICE ON (B)(6) 2013 AND "IT SEEMED TO WORK." SHE SWITCHED BACK TO THE ALLEGED INFUSION DEVICE, AND HER BLOOD GLUCOSE ELEVATED TO 200 MG/DL. SHE SWITCHED TO THE BACKUP INFUSION DEVICE AGAIN, AND HER BLOOD GLUCOSE DECREASED TO 129 MG/DL. HER NORMAL BLOOD GLUCOSE IS 140-160 MG/DL. PATIENT DISCONNECTED THE INFUSION SET AND PRIMED, AND NO INSULIN FLOWED FROM THE TUBE. SHE CHANGED THE INFUSION SET AND CARTRIDGE, BUT THIS DID NOT RESOLVE THE ISSUE. NO FURTHER ISSUES WERE NOTED DURING TROUBLESHOOTING. THE INFUSION DEVICE, CARTRIDGE, ADAPTER, AND INFUSION SET WERE REQUESTED FOR EVALUATION. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84834 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR PRABASTATIN SODIUM| HUMALOG U100| LISINOPRIL