VIDAS® B·R·A·H·M·S PCT¿

Description of Event or Problem

PRODUCT DESCRIPTION ************************ 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. ISSUE DESCRIPTION ********************* ON 08-AUG-2024, A CUSTOMER IN ITALY NOTIFIED BIOMÉRIEUX OF POTENTIAL OVERESTIMATED PATIENT RESULTS WHEN USING VIDAS® B·R·A·H·M·S PCT¿ REFERENCE (B)(4) LOT 1010576760 (EXPIRY 21-AUG-2025). FOUR (4) PATIENTS' RESULTS WERE IMPACTED: PATIENT 3 RESULTS: INITIAL RESULT: 9.25 NG/ML RETEST 1: 0.15 NG/ML RETEST 2: 0.17 NG/ML RETEST 3: 0.17 NG/ML. THE CUSTOMER STATED NO IMPACT TO PATIENTS, AS THE RESULTS WERE RETESTED BEFORE ANY OVERESTIMATED RESULTS WERE COMMUNICATED TO THE PHYSICIAN OR PATIENTS. 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.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY REGARDING OVERESTIMATED RESULTS PATIENT RESULTS WHEN USING VIDAS® B·R·A·H·M·S PCT¿ (REFERENCE 30450, LOT 1010576760). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: 1. DEVICE HISTORY RECORD THE REVIEW DID NOT HIGHLIGHT ANY ISSUE DURING MANUFACTURING, CONTROL AND PACKAGING PROCESSES FOR VIDAS® B·R·A·H·M·S PCT¿ (REFERENCE 30450, LOT 1010576760). THERE WAS NO CAPA, NON-CONFORMITY NOR QUALITY EVENT ON VIDAS® B·R·A·H·M·S PCT¿ (REFERENCE 30450) LINKED TO CUSTOMER 'S COMPLAINT. 2. COMPLAINT ANALYSIS AT THE DATE OF INVESTIGATION, NO OTHER COMPLAINTS WERE RECORDED FOR OVERESTIMATED RESULTS ON VIDAS® B·R·A·H·M·S PCT¿ (REFERENCE 30450, LOT 1010576760) 3. ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY 3.1 CONTROL CHARTS ANALYSIS THE COMPLAINTS LABORATORY ANALYZED THE RESULTS OF FOUR (4) INTERNAL SAMPLES TARGETED BETWEEN 0.33 NG/ML AND 9.03 NG/ML, ON SEVEN (7) DIFFERENT BATCHES OF VIDAS® B·R·A·H·M·S PCT¿ (REFERENCE 30450) INCLUDING CUSTOMER¿S LOT 1010576760 RELATED TO THE COMPLAINT. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS. THE CUSTOMER¿S LOT IS IN THE TREND OF THE OTHER LOTS. 3.2 TESTS ON INTERNAL SAMPLES THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES WITH THE RETAIN KITS OF VIDAS® B·R·A·H·M·S PCT¿ (REFERENCE 30450, LOT 1010576760). ALL SAMPLES¿ RESULTS ARE WITHIN THEIR EXPECTED SPECIFICATIONS. 3.3 LOG / ML2 ANALYSIS THE DATA FROM THE CUSTOMER¿S INSTRUMENT SHOW A SIGNIFICANT DIFFERENCE IN THE ASPIRATION OF STRIP WELL #6 FOR THE C3 POSITION COMPARED TO OTHER POSITIONS. THE PRESSURE VALUES ARE LOWER THAN USUAL BUT REMAINS BETWEEN THE THRESHOLDS. THIS COULD BE LINK TO A SMALL LEAK. HOWEVER, WITHOUT THE IMPACTED PUMP (ALREADY CHANGE BY FIELD SAFETY ENGINEER) IT IS NOT POSSIBLE TO FURTHER INVESTIGATE. 4. 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® B·R·A·H·M·S PCT¿ (REFERENCE 30450, LOT 1010576760) USING INTERNAL SAMPLES. CUSTOMER¿S ISSUE (IE OVERESTIMATED RESULTS) WAS NOT REPRODUCED BY COMPLAINTS LABORATORY DURING THE INVESTIGATION CONDUCTED ON INTERNAL SAMPLES MATERIALS. THE MAIN ROOT CAUSE MAY BE RELATED TO DEFECTIVE PUMP IN POSITION C3 , THE PRESSURE VALUES ARE LOWER AS USUAL BUT STAY BETWEEN THE THRESHOLDS. HOWEVER, WITHOUT THE IMPACTED PUMP IT IS NOT POSSIBLE TO IDENTIFY THE PROBLEM. ACCORDING TO THE ABOVE DATA, THE PERFORMANCE OF THE VIDAS® B·R·A·H·M·S PCT¿ (REFERENCE 30450, LOT 1010576760) IS WITHIN THE EXPECTED SPECIFICATIONS.