MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A. MINI VIDAS® ANALYZER

Model Number	99737
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 25-jun-2024, a customer in the united states notified biomérieux of observing quality control vidas test failure when using mini vidas® blue 110 / 220 v (ref.99737 serial number (b)(6)).The issue occurred on (b)(6) 2024 on side b, section b1.The last valid quality control vidas test was done on (b)(6) 2024.Between these two dates, three tests were performed with viads® bramhs procalcitonin (ref.30450-01).Quality control vidas test failure is not a malfunction; however, it could be associated with incorrect results (prior to the quality control vidas test failure).In the case of a quality control vidas test failure, biomérieux requests customers conduct a retrospective analysis from the last passed quality control vidas test until the present quality control vidas test failure.The retrospective analysis showed that among the three samples analyzed before the issue, one made on (b)(6)2024 gave a positive result (2.75 ng/ml), which means according the instruction for use of vidas bramhs pct: suggestive of presence of bacterial infection.Antibiotic therapy strongly recommended.The retest made on (b)(6) 2024, gave a negative result (0.09 ng/m, below the cutoff of 0.10 ng/ml).However, the patient received antibiotic treatment before the vidas bramhs pct test result obtained on (b)(6) 2024.Therefore, there was no harm due to wrong treatment in this case.The two other samples analyzed on (b)(6) 2024 and (b)(6) 2024 gave negative results and still negative after the retest.The customer confirmed also that there was no delay in rendering the results since the section a of the instrument was available.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
1-complaint description: on (b)(6) 2024, a customer in the united states notified biomérieux of observing quality control vidas test failure when using mini vidas® blue 110 / 220 v (ref.(b)(4) serial number (b)(6)).2-problem confirmation: a field service engineer (fse) was dispatched in order to repair and qualify the instrument on (b)(6)2024.The fse investigated the issue at the customer site a quality control vidas (qcv) test failure is not an abnormal behavior.It means that the qcv played its role as a functional control.This control is meant to detect residual risks, that are rare and sudden.Those risks are already present and accepted into the system risk analysis.3-detailed results of the investigation: the fse performed several actions: - visual inspection of the pump seals, fse found a visual clot on position b1.- visual inspection on the tray, on the door, on the shield insulate plate and on the frame bottom.- performed a vidas pump tester, position b1 was below 140 (exact value is 21).- performed a vidas pump cleaner on position b1.- performed a vidas pump tester after the cleaning, all the values were above 140.- check for leak presence.- system qualification.Qcv failure root cause was a clog in position b1.Action to solve it: pump channel cleaning.After the fse intervention, the system was operating per manufacturing specifications.

• Brand Name: MINI VIDAS® ANALYZER
• Common Device Name: MINI VIDAS® ANALYZER
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer (Section G): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: romain marti ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 19690121
• Report Number: 9615037-2024-00022
• Device Sequence Number: 7122152
• Product Code: JJE
• UDI-Device Identifier: 03573026140441
• UDI-Public: 03573026140441
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 99737
• Device Catalogue Number: 99737
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown