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

Catalog Number 30450-01

Device Problem False Positive Result (1227)

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

Event Date 12/20/2023

Event Type  Injury  

Event Description

On 20-dec-2023, a customer in the united states notified biomérieux of potential false-positive results leading to incorrect patient treatment when using vidas brahms procalcitonin 60t (ref.(b)(4), lot 1010079250, expiry date: 20-nov-2024).The customer tested a pediatric patient sample.The customer reported that with one strip where it appears the sample was not transferred to the appropriate well.The sample was initially resulted as positive, but upon re-running it was negative.Here the result obtained and the correction after retesting: 29.17 ng/ml that was corrected to 0.70 ng/ml customer continued to run samples on the b side of the minividas instrument, verified all strips to confirm that sample transfer occurred.The customer completed a quality control vidas (qcv) test at the request of biomérieux field service engineer (fse).Qcv passed with no errors, indicating the instrument was working correctly.The customer noted they will continue running qcv weekly.Discussion with the customer indicated the most likely root cause of the event was due to clotted / lipemic samples.It is written in the instructions for use that "it is recommended not to use samples that are hemolyzed, lipemic or icteric and, if possible, to collect a new sample." on 21-dec-2023, the customer stated that due to overestimation of results a spinal tap was performed unnecessarily on a pediatric patient.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

1) context of the complaint: on (b)(6) 2023, a customer in the united states notified biomérieux of potential false-positive results leading to incorrect patient treatment when using vidas brahms procalcitonin 60t (ref.(b)(4), lot: 1010079250, expiry date: 20-nov-2024).2) customer material: no patients samples available for testing purpose.3) investigation outcomes: 3-1) complaint analysis: at the time of the investigation, only this customer's complaint has been recorded for false positive routine sample testing on vidas b.R.A.H.M.S pct ref: (b)(4) lot: 1010079250.3-2) analysis and tests conducted by complaints laboratory.Control chart analysis: this analysis was carried out: on four (4) internal samples with a respective target at 0.12 ¿ 0.34 ¿ 1.22 and 30.7 ng/ml.On seven (7) lots of vidas® b.R.A.H.M.S pct ref: (b)(4) including the lot: 1010079250 mentioned by the customer.The analysis of the control charts showed that all results were within specifications, and the lot: 1010079250 is in the trend compared to the other lots.Test on internal samples: the complaints laboratory tested: three (3) internal samples with a respective target at 0.08 ¿ 0.34 ¿ 40.9 ng/ml.On vidas® b.R.A.H.M.S pct ref: (b)(4), lot: 1010079250 and other lot: 1010128530 used for reference.The results complied with the specifications, and they were not significantly different compared to those observed before the lot release.Biomérieux does not observe any evolution over time of these samples activity.Reproducibility testing.The complaints laboratory tested three (3) internal samples (target at 0.12 ng/ml ; 0.34 ng/ml and 0.49 ng/ml ) in duplicate on the retain kit vidas® b.R.A.H.M.S pct ref: (b)(4), lot: 1010079250.The results complied with the specifications.The coefficient of variation is compliant with the expectation (cv < 5%).Conclusion: the complaints laboratory did not reproduce the issue reported by the customer (result too high) when testing internal samples on vidas® b.R.A.H.M.S pct ref: (b)(4), lot: 1010079250.The hypothesis could be preanalytical conditions (presence of a clot in the sample or lipemic sample).Without patient sample return, further investigation could not be pursued to explain the positive results observed by the customer.According to the data mentioned above, there is no reconsideration vidas® b.R.A.H.M.S pct ref: (b)(4), lot: 1010079250.

• 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: romain marti ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 18396654
• MDR Text Key: 331358087
• Report Number: 8020790-2023-00051
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 30450-01
• Device Lot Number: 1010079250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1