BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCHEK SOFTCLIX STERILE LANCETS

    MDR report key: 211162 · Received February 22, 1999

    Report

    Report Number
    MW1015755
    Event Type
    Malfunction
    Date Received
    February 22, 1999
    Report Date
    February 19, 1999
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATES THE PRODUCT IS NOW LABELED "NEW LOOK. SAME TRUSTED PRODUCT". THE FORMER PRODUCT ALLOWED HIM TO INSERT THE USED LANCET INTO THE CENTER OF THE TWIST-OFF CAP FOR EASY, SAFE DISPOSAL. PICTURE THE ROUND TWIST-OFF PLASTIC CAP AS A COIN. HE WOULD STICK THE NEEDLE INTO THE CENTER OF ONE OF THE SIDES, NOT THE EDGE. THE NEW PRODUCT IS OF A DIFFERENT MATERIAL MAKE-UP (AND DIFFERENT COLOR-WHITE). WITH THE NEW PRODUCT, WHEN ONE ATTEMPTS TO DO THE SAME TO DISPOSE OF THE NEEDLE, THE NEW MATERIAL EXTRUDES THE LANCET; ACTUALLY REPELS IT, IF YOU WILL. THIS NOW MEANS THE CONTAMINATED NEEDLE IS EXPOSED AND IS A HAZARD. THERE MAY BE OTHER DIABETICS WHO ALSO PREFER THIS METHOD OF DISPOSAL. THIS IS THE ONLY LANCET THAT WORKS WITH HIS PUNCTURE DEVICE. HE WILL HAVE TO EMPLOY A SEPARATE CONTAINER FOR DISPOSAL NOW. HE IN NOT AN INSULIN DEPENDENT DIABETIC, SO HE DID NOT USE SYRINGES AND DID NOT USE SUCH A CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHEK SOFTCLIX STERILE LANCETS LANCET FMK ROCHE DIAGNOSTICS CORP. * 9829614

    Patients

    Seq Age Sex Outcome Treatment
    1 *