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)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 15-apr-2024, a customer in the united states notified biomérieux of observing quality control vidas (qcv) test failure when using mini vidas blue 110 / 220 v (ref.99737 serial number (b)(6)).The qcv error appeared on 15-apr-2024.The position a2 failed two times the qcv test.The section a was then disabled.The last conform quality control vidas (qcv) test was made on 08-apr-2024.Between the 08-apr-2024 and 15-apr-2024, thirteen samples were concerned and were then re-tested after the qcv issue appeared.From the thirteen samples, one sample analyzed on 15-apr-2024 gave a result of 0.55 ng/ml for vidas® brahms pct before the issue and < 0.05 ng/ml for the re-test made the same day.Qcv done on 18-apr-2024 was valid.The customer use to perform the qcv test on a weekly basis as mandatory.The customer confirmed that the discrepant result did not lead to any adverse impact to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
1-complaint description ***********************" on 15-apr-2024, customer in the united states contacted biomérieux following a quality control vidas (qcv) alert, on position a2 on mini vidas® (serial number: (b)(6) customer performed a second qcv which failed again.A field service engineer (fse) was dispatched in order to repair and qualify the instrument on 18-apr-2024 between the customer contact date (15 apr 2024) and the fse intervention (18-apr-2024) the customer didn't use section a.2-problem confirmation *********************** a qcv failure is not an abnormal behavior.It means that the qcv test 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.An fse was dispatched in order to repair and qualify the instrument on 18-apr-2024.The fse investigated the issue at the customer site.3-detailed results of the investigation *********************** the fse performed several actions: - section visual inspection - visual inspection (on the tray, on the door, on the shield insulate plate, on the frame bottom ) - perform pump cleaner on the section a - perform pump tester (pump tester value a2: 197, all other values >180) - check door plunger ball.- check stricker plate.- check spring integrity - check free and smooth vertical movement of spr blocks - check spr block alignment - check tower height - check tray depth - check pump block (movement, pump sensor.After all the previous check, no issue was detected.- system qualification qcv failure root cause was: pump channel clogged on position a2.Action to solve it: pump cleaner used.Following 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: 19217075
• Report Number: 9615037-2024-00017
• Device Sequence Number: 8194692
• Product Code: JJE
• UDI-Device Identifier: 03573026140441
• UDI-Public: 03573026140441
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K923579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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