BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT CARTRIDGE

    MDR report key: 2993208 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-00353
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 16, 2013
    Report Date
    August 1, 2025
    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
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED. RESULT SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE THE COMPLAINT CANNOT BE VERIFIED. AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE LOT IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPLICATED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER AND EXPIRATION DATE OF THE PRODUCT IS UNKNOWN. THE MEDICATION START DATE IS UNKNOWN. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT'S MOTHER REPORTED THERE WAS MOISTURE IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE FROM TIME TO TIME. PATIENT USES THE INSERTION ASSIST DEVICE AND WEARS THE INFUSION DEVICE IN A CASE IN HIS POCKET. MOTHER WAS UNSURE OF WHERE THE LEAK ORIGINATED OR IF THE CONDENSATION WAS WATER OR INSULIN. MOTHER STATED THEY USUALLY WIPE OUT THE CARTRIDGE COMPARTMENT WITH A CLOTH, BUT NEVER SMELLED ANY INSULIN. ON CALL BACK ON (B)(6) 2013 MOTHER STATED SHE WAS UNSURE IF THE CONDENSATION WAS WATER OR INSULIN BUT WOULD THINK IT IS INSULIN ALTHOUGH SHE STATED IT DID NOT SMELL LIKE INSULIN. MOTHER STATED THE ISSUE CONTINUES TO OCCUR USING ALL NEW ACCESSORIES. MOTHER REPORTED THE CONDENSATION FORMS AT RANDOM TIMES INTERMITTENTLY. MOTHER STATED SHE WAS UNSURE IF THERE WAS A LEAK IN THE SYSTEM. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INSULIN CARTRIDGE, INFUSION SET, AND ADAPTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97826 ACCU-CHEK ® SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ROCHE HEALTH SOLUTIONS INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male INSULIN| INSULIN