BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® B·R·A·H·M·S PCT¿

    MDR report key: 20334145 · Received September 30, 2024

    Report

    Report Number
    8020790-2024-00012
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    PRI
    PMA / PMN Number
    K162827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN INDIA OF POTENTIAL OVERESTIMATED PATIENT RESULTS WHEN USING VIDAS® B·R·A·H·M·S PCT¿ REFERENCE 30450 LOT 1010472390 (EXPIRY 16-JUN-2025). THE CUSTOMER CLAIMED THAT THE VIDAS® B·R·A·H·M·S PCT¿ RESULTS WERE COMING HIGH IN ALMOST ALL THE SAMPLES. MOREOVER THE CONCERNED PATHOLOGIST CLAIMED THAT THE CONTROLS ARE ALSO COMING IN ON THE HIGHER SIDE. AT THE TIME OF REPORT, NO PATIENT VALUES HAD BEEN PROVIDED BY THE CUSTOMER. NOTE: NEW INFORMATION PROVIDED BY THE CUSTOMER AFTER THE REPORT WAS SUBMITTED STATED THAT THERE WAS A MISUNDERSTANDING OF A NEW DOCTOR ABOUT THE REPEATABILITY AND HOW TO OBTAIN THE MEAN LAB VALUE FOR THE INTERNAL QUALITY CONTROL OF PCT. A BIOMÉRIEUX FIELD APPLICATION SPECIALIST VISITED THE CUSTOMER SITE AND PROVIDED TRAINING. THE CUSTOMER CONFIRMED THERE WERE NO ISSUES AND NO SAMPLES WERE AFFECTED. ADDITIONALLY, AN INTERNAL INVESTIGATION WAS COMPLETED. INVESTIGATION 1. DEVICE HISTORY RECORD THE REVIEW DID NOT HIGHLIGHT ANY ISSUE DURING MANUFACTURING, CONTROL AND PACKAGING PROCESSES FOR VIDAS® BRAHMS PCT REF 30450 LOT 1010472390. 1. COMPLAINT ANALYSIS THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 2. TEST/ANALYSIS PERFORMED **CONTROL CHARTS ANALYSIS** THE COMPLAINTS LABORATORY ANALYZED THE RESULTS OF NINE (9) INTERNAL SAMPLES ON SEVEN (7) DIFFERENT LOTS OF VIDAS® BRAHMS PCT REF 30450 INCLUDING CUSTOMER¿S LOT 1010472390. => THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS. CUSTOMER¿S LOT IS IN THE TREND OF THE OTHER LOTS. **TESTS PERFORMED BY COMPLAINT LABORATORY ** - ON INTERNAL SAMPLES: THE COMPLAINTS LABORATORY TESTED SEVEN (7) INTERNAL SAMPLES WITH THE RETAIN KITS VIDAS® BRAHMS PCT 1010472390. => ALL SAMPLES RESULTS ARE WITHIN THEIR EXPECTED SPECIFICATIONS. 4. ROOT CAUSE ANALYSIS AND CONCLUSION ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON RETAIN KITS VIDAS® BRAHMS PCT 1010472390 USING INTERNAL SAMPLES. CUSTOMER¿S ISSUE, IE OVERESTIMATED RESULTS, WAS NOT REPRODUCED BY COMPLAINTS LABORATORY DURING THE INVESTIGATION CONDUCTED ON INTERNAL SAMPLES MATERIALS. ACCORDING TO THE LOCAL CUSTOMER SERVICE, ISSUE WAS RELATED TO LACK OF TRAINING FOR THE CUSTOMER. THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® BRAHMS PCT REF 30450 1010472390.

    Description of Event or Problem · 0

    INTENDED USE: VIDAS® B·R·A·H·M·S PCT¿ IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B¿R¿A¿H¿M¿S PCT¿ AIDS IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION, FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ ALSO AIDS IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS (LRTI) (INCLUDING COMMUNITY ACQUIRED PNEUMONIA, EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ACUTE BRONCHITIS) SEEN DURING MEDICAL CONSULTATIONS, INCLUDING AT THE EMERGENCY DEPARTMENT. DESCRIPTION OF THE ISSUE: ON 04-SEP-2024, A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX OF POTENTIAL OVERESTIMATED PATIENT RESULTS WHEN USING VIDAS® B·R·A·H·M·S PCT¿ REFERENCE (B)(4) LOT 1010472390 (EXPIRY 16-JUN-2025). THE CUSTOMER IS CLAIMING THAT THE VIDAS® B·R·A·H·M·S PCT¿ RESULTS ARE COMING HIGH IN ALMOST ALL THE SAMPLES. MOREOVER THE CONCERNED PATHOLOGIST IS CLAIMING THAT THE CONTROLS ARE ALSO COMING IN A HIGHER SIDE. AT THIS TIME OF THE ASSESSMENT, THERE IS NO INFORMATION ABOUT THE NUMBER OF PATIENT SAMPLES IMPACTED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE REFERENCED ISSUE. NO DELAY IN RENDERING THE RESULT WAS MENTIONED BY THE CUSTOMER. THE PRODUCT, VIDAS® B·R·A·H·M·S PCT¿ REFERENCE (B)(4), IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, A SIMILAR PRODUCT, VIDAS® B·R·A·H·M·S PCT¿ REFERENCE (B)(4) IS MARKETED IN THE UNITED STATES. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040481 VIDAS® B·R·A·H·M·S PCT¿ VIDAS® B·R·A·H·M·S PCT¿ PRI BIOMÉRIEUX SA 1010472390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown