BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2850143 · Received November 21, 2012

    Report

    Report Number
    2183996-2012-01775
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT REPORTED 'NO INSULIN IS GETTING TO ME'. SHE STATED THAT ON (B)(6) 2012 SHE WAS VERY THIRSTY, NOT HUNGRY, AND HAD GENERAL SYMPTOMS OF LACK OF INSULIN. SHE CHANGED THE INSULIN CARTRIDGE AND PRIMED THE INFUSION SET AND LATER E4 (OCCLUSION) ERROR WAS DISPLAYED. SHE AGAIN CHANGED THE INFUSION SET. ON (B)(6) 2012 SHE WAS TOO ILL TO GO TO WORK. ON (B)(6) 2012 SHE HAD NO ENERGY AND HAD TIGHTNESS IN HER CHEST AND WAS VERY THIRSTY. SHE DID NOT HEAR HER INFUSION DEVICE WORKING AND SWITCHED TO INSULIN INJECTIONS. DURING TROUBLESHOOTING, THE PT CHANGED THE INFUSION AND PRIMED AND NO INSULIN WAS DELIVERED AND NO ERROR MESSAGE WAS DISPLAYED. SHE REMOVED THE INSULIN CARTRIDGE AND WAS ABLE TO RETRACT AND EXTEND THE PISTON ROD. SHE PROGRAMMED A 10 UNIT BOLUS AND AFTER 1.6 UNITS OF INSULIN WAS DELIVERED THE INFUSION DEVICE NO LONGER MADE ANY SOUND BUT CONTINUED TO COUNT DOWN THE BOLUS. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN