BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMA-COMBOSTIX®

    MDR report key: 19793993 · Received July 22, 2024

    Report

    Report Number
    3002637618-2024-00076
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 21, 2024
    Report Date
    October 21, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDM
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER, KIMBALL ELECTRONICS POLAND (KEPS), INVESTIGATED THE ALLEGATIONS MADE AGAINST THE IMPACTED LOT OF HEMACOMBISTIX, WHERE THE BOTTLE CONTAINED URISTIX 4 STRIPS INSTEAD OF THE HEMACOMBISTIX STRIPS. THE MANUFACTURER PERFORMED AN INVESTIGATION INTO THE PRODUCTION RECORDS AND FOUND BOTH PRODUCTS WERE BOTTLED IN SEQUENCE WITH THE URISTIX 4 AND HEMACOMBISTIX. IN ADDITION, RETAIN TESTING WAS REVIEWED AND FOUND NO ISSUES RELATED TO THEIR PROCESS. ALL BOTTLES CONTAIN THE CORRECT AMOUNT AND TYPE OF HEMACOMBISTIX. KEPS COULD NOT CONFIRM THE CUSTOMER'S ISSUES BY INTERNAL TESTING BUT ACKNOWLEDGED THAT THE MIX-UP COULD HAVE BEEN DONE ON THE SLIT/FILL/CAP PRODUCTION LINE WHERE INSUFFICIENT LINE CLEARANCE BETWEEN PRODUCTS MANUFACTURING AND SHIFTS MAY HAVE BEEN THE CAUSE. IN AN ABUNDANCE OF CAUTION, KEPS HAS INCREASED THE OPERATOR¿S AWARENESS BY IMPLEMENTING QUALITY ALERTS, ENSURING THAT THE PROBLEM WILL NOT OCCUR IN THE FUTURE. TO IMPROVE THE URINE STRIPS SLIT, FILL AND CAP PROCESS, A CORRECTIVE ACTION HAS BEEN IMPLEMENTED BY KEPS TO ADDRESS THE ISSUE AND TO PREVENT FUTURE REOCCURRENCES. THIS APPEARS TO BE AN ISOLATED INCIDENT, WHICH OCCURRED WITH ONE BOTTLE. THE CAUSE OF THE EVENT IS UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PHOTOS OF THE INCIDENT HAS BEEN RECEIVED FROM THE CUSTOMER. FURTHER INVESTIGATED INTO MANUFACTURING AND RECORDS IS REQUIRED TO FIND THE ROOT CAUSE. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT WHEN THEY USED A NEW LOT OF HEMA-COMBISTIX (LOT 311041) WITH THEIR CLINITEK STATUS+, RESULTS FOR THE URISTIX4 WERE PRINTED (GLU, PRO, NIT, WBC). ALL STRIPS IN THE BOTTLE LOOKED IDENTICAL. THE CUSTOMER HAS 3 BOTTLES OF HEMA-COMBISTIX LOT 311041, BUT ONLY 1 WAS IN USE. THE CUSTOMER BELIEVES THESE REAGENT STRIPS WERE PACKAGED IN A BOTTLE OF HEMA-COMBISTIX REAGENT STRIPS. THE ONE AFFECTED BOTTLE HAS A LABEL FOR HEMA-COMBISTIX, BUT IT IS PACKED WITH STRIPS THAT ARE DIFFERENT THAN THE OTHER 2 BOTTLES OF HEMA-COMBISTIX FROM THE SAME LOT. THE CUSTOMER STATED, ¿INCORRECT¿ STRIPS ARE ONLY INSIDE ONE BOTTLE; THE OTHER 2 BOTTLES HAVE STRIPS THAT APPEAR VISIBLY DIFFERENT AND READ CORRECTLY AS HEMA-COMBISTIX ON THE STATUS+ INSTRUMENT. INCORRECT PATIENT RESULTS WERE GENERATED PRIOR TO NOTICING AN ISSUE WITH THE STRIP. THE CUSTOM CLAIMS THERE IS NO POTENTIAL THAT THE CUSTOMER MIXED UP THE STRIPS IN ERROR BECAUSE THEY DO NOT USE URISTIX (GLU, PRO). THERE WAS NO REPORT OF HARM DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003606 HEMA-COMBOSTIX® HEMO-COMBOSTIX CDM SIEMENS HEALTHCARE DIAGNOSTICS INC. 311041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown