MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® B·R·A·H·M·S PCT ¿

Model Number 30450-01

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On (b)(6) 2023, a customer from united states notified biomérieux of obtaining underestimated result when testing patient sample with vidas brahms procalcitonin 60t (ref: (b)(4), batch number: 1009431890, expiry date: 15-nov-2023).The customer performed test on patient samples with vidas®brahms procalcitonin 60t (ref: (b)(4), lot#: 1009431890).He found foam/bubbles on one of the reagent strips when running.The results were underestimated as follow: first test: 0,28.The customer reran test within an hour, and he obtained the following result: second test: 0,95.The underestimated result was sent to the physician before the customer realized the issue.They corrected the result and reported it to the physician.The customer stated that the change in result did not modify the treatment.Patient was not harmed.The qcv was done and correct.There is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from united states that they obtained underestimated results when testing patient sample with vidas brahms procalcitonin (ref.30450-01 lot 1009431890) investigation: device history record: the review did not highlight any issue during manufacturing for vidas brahms procalcitonin (pct) lot 1009431890/231115.Complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.Tests/analysis performed: customer¿s material: the customer strip involved was not available for the investigation.Complaints laboratory performed tests: study of internal samples control charts: this analysis was carried out: on 4 internal sera vidas pct with targets between 0.08 to 1.22 ng/ml.On 7 batches of vidas pct including the batch mentioned by the customer all values are within their specifications, customer¿s lot is in the trend of the other lots.Study on internal samples: the complaints laboratory tested 2 internal samples with following targets (0.23-0.45) and (0.92-1.52) on the retain kit vidas pct lot 1009431890 (lot used by the customer).Both sample results are within their expected specifications.Root cause analysis and conclusion: according to all information above, no anomaly was highlighted during the control chart analysis and the analysis of quality data for vidas brahms procalcitonin lot 1009431890.In the absence of return strip, it is not possible to pursue further investigations.The most likely hypothesis would be the presence of bubbles/foam in the strip before the launch of the run in the case, for example, of a shock of the strip.According to the above data, the kit vidas brahms procalcitonin lot 1009431890 is within the expected performance.

• Brand Name: VIDAS® B·R·A·H·M·S PCT ¿
• Type of Device: VIDAS® B·R·A·H·M·S PCT ¿
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: ines el oueryemmi ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16215854
• MDR Text Key: 309078658
• Report Number: 8020790-2023-00007
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1009431890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1