MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® BRAHMS PROCALCITONIN; VIDAS® BRAHMS PROCALCITONIN 60T

Model Number 30450-01

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer from (b)(6) notified biomérieux of obtaining out of range high result when testing external quality control with vidas brahms procalcitonin 60t (ref.30450-01, batch number: 1008987800, expiry date: 19-mar-2023).The external quality control is l1 from audit micro control (lot 06799) and the expected ranges established by the customer are: mean: 0.50 [0.44-0.56].During may-2022, the customer obtained out range too high results at different moment: 03-may: 0.58, 04-may: 0.58, 07-may: 0.78, 07-may: 0.58, 24-may: 0.57, 25-may: 0.57, 28-may: 0.58, 29 may: 0.57, 29-may: 0.57, to be noted that the calibration of vidas brahms procalcitonin 60t (ref.30450-01, batch number: 1008987800,) performed on 20-apr-2022 and 05-may-2022 were valid.As this was an external quality control, no patient sample was involved.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from the united states of obtaining out of range high result when testing external quality control (quality control sample l1 from audit micro control lot 06799) with vidas® brahms procalcitonin 60t (ref.30450-01, batch number: 1008987800, expiry date: 19-mar-2023).The customer who has established his own range for l1 from amc [0.44-0.56] observed a high distribution of results between 0.47 and 0.78 ng/ml leading to data above the +2 sd.We do not have information regarding the protocol applied when establishing the range especially regarding the number of lots used, number of calibrations, number of repetition performed.1) complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.2) quality control records there is neither capa nor non-conformity linked to this issue on this vidas assay.3) analysis and tests conducted by complaints laboratory 3.1) control chart analysis this analysis was carried out: on four (4) internal samples with a respective target at 0.34 / 0.49 / 1.22 and 3.03 ng/ml.On seven (7) batches of vidas b.R.A.H.M.S pct including the customer¿s lot 1008987800.The analysis of the control charts showed that all results are within specifications and the lot mentioned by the customer is in the trend compared to the other lots.3.2) test on internal samples the complaints laboratory carried out a repeatability testing on vidas b.R.A.H.M.S pct lot 1008987800 (retain kit) using an internal sample with a target at 0.49 ng/ml.For reminder, the target of the quality control established by the customer is 0.50 ng/ml and target from amc is 0.52 ng/ml.The internal sample, tested 9 times, gave results between 0.48 and 0.55 ng/ml with a mean at 0.51 ng/ml.The distribution of the results are better than the one observed by the customer on the quality control sample (between 0.47 and 0.78 ng/ml).All the results are close to the target of this sample and complied with the specification.Moreover, they are not significantly different to the one observed before the batch release.We do not observe any evolution over time on this internal sample.3.3)test on a natural sample from a blood sample the complaints laboratory carried out a repeatability testing on vidas b.R.A.H.M.S pct lot 1008987800 (retain kit) using a blood donor sample.The sample tested 10 times gave systematically a result < 0.05 ng/ml.No overestimated result was observed.4) conclusion the complaints laboratory did not reproduce the issue reported by the customer (result too high) when testing in repeatability a sample from a blood donor and an internal sample.Moreover, the distribution observed on the internal sample was significantly lower than the one observed by the customer.Without the customer¿s material available and relevant information concerning the operating conditions and the protocol applied during the establishment of the acceptable range (especially regarding the number of lots used, number of calibrations, number of repetition performed), it was not possible to pursue further the investigation and we did not manage to identify any obvious root cause.The phenomena observed by the customer can be due to one or a combination of causes listed below: the quality control sample processed by the customer (e.G stability, homogenization, and handling).The calibration results.The establishment of the range and target.According to the investigation outcomes, there is no reconsideration of vidas b.R.A.H.M.S pct ref.30450-01 lot 1008987800.

• Brand Name: VIDAS® BRAHMS PROCALCITONIN
• Type of Device: VIDAS® BRAHMS PROCALCITONIN 60T
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: sandra locca-bernard ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14885935
• MDR Text Key: 295141734
• Report Number: 8020790-2022-00071
• 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: 08/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1008987800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/29/2022
• Supplement Dates FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1