VIDAS® C. DIFFICILE TOXIN A & B

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER IN CHILE THAT A USER HAD AN ACCIDENT INVOLVING THE BREAKAGE OF REAGENT BOTTLE WHEN USING VIDAS CD A/B 60 TESTS (REF. (B)(4), LOT 1009724640, EXPIRY ON 30-SEP-2023). INVESTIGATION RESULTS: NO CUSTOMER MATERIAL WAS AVAILABLE FOR TESTING PURPOSES. 1. COMPLAINT ANALYSIS. AT THE DATE OF INVESTIGATION, NO OTHER COMPLAINTS WERE RECORDED FOR REAGENT BREAKAGE ON VIDAS CD A/B 60 TESTS (REF. (B)(4) LOT 1009724640. 2. TESTS CONDUCTED BY BIOMÉRIEUX'S COMPLAINTS LABORATORY. THE COMPLAINTS LABORATORY OBSERVED THE INTEGRITY OF DIFFERENT VIALS OF STANDARDS AND CONTROLS OF THE SAME LOT AS THE CUSTOMER'S, VIDAS CD A/B 60 TESTS (REF. 30118) LOT 1009724640. THE OBSERVED VIALS WERE FROM THE RETAINED KIT BUT ALSO REMAINING VIALS FROM THE LABORATORY'S QUALITY CONTROL.. CONCERNED COMPONENTS: STANDARD S1 LOT 2167980 (24 REMAINING VIALS TESTED); CONTROL C1 LOT 2167950 (8 REMAINING VIALS TESTED); CONTROL C2 LOT 2167960 (13 REMAINING VIALS TESTED); CONTROL C3 LOT 2167970 (6 REMAINING VIALS TESTED). COMPONENTS OF THE RETAIN KIT TESTED: NO ISSUE OBSERVED. THERE WAS NO ANOMALY OBSERVED ON THE TESTED VIALS AND NO BREAKAGE ISSUE WHEN TRYING TO OPEN THEM EXCEPT FOR ONE (1) VIAL OF STANDARD S1: THE VIAL WAS BROKEN AT ITS NECK WHEN OPENING IT THE SECOND TIME. CONCLUSION: THE COMPLAINTS LABORATORY REPRODUCED THE CUSTOMER¿S ISSUE ON ONE (1) VIAL DURING THE TESTS PERFORMED ON COMPONENTS FROM THE RETAINED KIT OF VIDAS C. DIFFICILE TOXIN A & B (CDAB) LOT 1009724640 AND ON REMAINING VIALS OF THE SAME LOTS OF CONTROLS. BIOMÉRIEUX ASSESSED THE RISK ASSOCIATED WITH THIS ISSUE. ACCORDING TO INVESTIGATION OUTCOMES, THE PROBABILITY IS NOT CHANGED. THEREFORE, IT WAS DETERMINED THAT THE OVERALL RISK IS IRRELEVANT. ACCORDING TO THE INVESTIGATION, THERE IS NO RECONSIDERATION OF VIDAS CD A/B 60 TESTS (REF. 30118) LOT 1009724640'S PERFORMANCE.

Description of Event or Problem

ON (B)(6) 2023, A CUSTOMER IN CHILE NOTIFIED BIOMÉRIEUX THAT A USER HAD AN ACCIDENT INVOLVING THE BREAKAGE OF REAGENT BOTTLE WHEN USING VIDAS CD A/B 60 TESTS (REF. 30118, LOT 1009724640, EXPIRY ON 30-SEP-2023). THE CUSTOMER REPORTED THAT THE KIT'S C2 CONTROL VIAL LID WAS CLOSED SO TIGHTLY THAT, WHEN TRYING TO OPEN THE CONTROL VIAL, THE BOTTLE BROKE IN THE USER¿S HAND, LEAVING THE LID ON AND CUTTING THE TIPS OF BOTH INDEX FINGERS. THE CUSTOMER NOTED THAT THE BOTTLE DID NOT APPEAR TO HAVE ANY DAMAGE TO THE CONTROL VIAL PRIOR TO ATTEMPTING TO OPEN IT. IT IS REPORTED THAT THE USER CUT WAS DEEP AND REQUIRED STITCHES. SHE HAS NO INFECTION, BUT SOUGHT MEDICAL CARE AND IS ON MEDICAL LEAVE AS A RESULT OF THE INCIDENT. NOTE - PRODUCT REFERENCE 30118 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, THERE IS A SIMILAR DEVICE, PRODUCT REFERENCE 30118-01. A BIOMÉRIEUX INTERNAL INVESTIGATION WAS INITIATED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS (SUSPECTED THROMBUS AND AORTIC INSUFFICIENCY) COULD NOT BE CONCLUSIVELY DETERMINED. A SPECIFIC CAUSE FOR THE REPORTED GASTROINTESTINAL BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. THE SUBMITTED LOG FILE CONTAINED EVENTS SPANNING FROM (B)(6) 2023. THE LOG FILE APPEARED TO SHOW THE SYSTEM OPERATING AS INTENDED AT THE SET SPEED. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM WAS NOT PROVIDED BY THE ACCOUNT. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (REV. C) LISTS THROMBUS AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT CARE AND MANAGEMENT SECTION OF THE INSTRUCTIONS FOR USE OUTLINES THE INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS. INFORMATION REGARDING RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO RANGE IS ALSO PROVIDED IN THIS SECTION. THIS DOCUMENT WARNS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.