BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3313100 · Received August 28, 2013

    Report

    Report Number
    2183996-2013-01634
    Event Type
    Malfunction
    Date Received
    August 28, 2013
    Date of Event
    July 31, 2013
    Report Date
    November 5, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    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 ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTION TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE HISTORY SHOWS E4 (OCCLUSION) ERROR MESSAGE. THE CUSTOMER DID NOT ALWAYS SOLVE THE E4 ERROR MESSAGE CORRECTLY. THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED TRANSFER SETS. THE TUBING CONNECTOR NEEDLE HAD DAMAGES (CLICK-LEGS WERE BENT ON ONE OUT OF TWO). THE FLOW AND LEAK TESTS WERE IN ACCORDANCE WITH SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 0230069 WAS VERIFIED AND FOUND WITHIN SPECIFICATIONS. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. NO LOT NUMBER IS KNOWN; THEREFORE, NO RETENTION SAMPLE COULD BE INVESTIGATED. THE ADAPTER PASSED THE OPTICAL INSPECTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED HE EXPERIENCED HYPERGLYCEMIA FOR 3 DAYS AND BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. HIS BLOOD GLUCOSE WAS IN THE 600 MG/DL RANGE, AND HE DELIVERED A "LARGE" INSULIN INJECTION AS TREATMENT. THE ALLEGED INFUSION DEVICE DISPLAYED AN OCCLUSION ERROR DURING PRIMING, AND HE CHANGED ALL THE ACCESSORIES BUT THIS DID NOT RESOLVE THE ISSUE. HE SWITCHED TO THE BACKUP INFUSION DEVICE USING THE SAME ACCESSORIES AND HAS EXPERIENCED NO FURTHER ISSUES. HE BELIEVES THE DELIVERY ISSUE BEGAN PRIOR TO THE OCCLUSION ERROR. THE INFUSION DEVICE, ADAPTER, CARTRIDGE, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR EVALUATION. HE 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
    422292 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR NOVOLOG INSULIN| ACCU-CHEK AVIVA METER