MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS PROCALCITONIN

Catalog Number 30450

Device Problem Low Test Results (2458)

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

Event Date 09/28/2021

Event Type  malfunction  

Event Description

Product description: vidas® b·r·a·h·m·s pct¿ is an automated test for use on the vidas® family of instruments for the determination of human procalcitonin in human serum or plasma (lithium heparin) using the elfa (enzyme-linked fluorescent assay) technique.Used in conjunction with other laboratory findings and clinical assessments, vidas® b·r·a·h·m·s pct¿ aids in the risk assessment of critically ill patients on their first day of icu admission, for progression to severe sepsis and septic shock.Used in conjunction with other laboratory findings and clinical assessments, vidas® b·r·a·h·m·s pct¿ also aids in decision making on antibiotic therapy for patients with lower respiratory tract infections (lrti) (including community acquired pneumonia, exacerbation of chronic obstructive pulmonary disease, acute bronchitis) seen during medical consultations, including at the emergency department.Issue description: on (b)(6) 2021, a customer from (b)(6) notified biomérieux of obtaining out of range too low result when testing external quality control sample with vidas brahms procalcitonin 60t (ref.30450, batch number: 1008722440, expiry date: 27-oct-2022).The expected result of sample h8 of the cscq was 11.6 ng/ml - qualab ranges [8.3-15].On (b)(6) 2021, the customer obtained <0.05 ng/ml with vidas brahms procalcitonin 60t (ref.30450, batch number: 100872244).To be noted that the calibration was valid on (b)(6) 2021 and control c1 and c2 were also valid on (b)(6) 2021 and on 28-sep-2021 respectively.Based on the available information at the time of this assessment, there is no report of a potential patient¿s impact of this issue, as it is an external quality control, or any delayed results.A biomérieux internal investigation has been initiated.Note: reference 30450 is not registered in the united states.The u.S.Similar device is product reference 30450-01.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of obtaining out of range (too low) results when testing an external quality control (cscq procalcitonina sample h8) with vidas pct ref.30450 lot 1008722440.The customer¿s external qc sample was not available to be submitted for the investigation.1.Device history record the analysis of the batch history record of vidas pct ref.30450 lot 1008722440 did not highlight any issue during manufacturing.2.Tests and analysis performed.2.1.Control chart analysis during control chart analysis, the analysis was carried out for four (4) internal samples (with respective target at 0.08, 0.30, 0.87 and 10.90 ng/ml) on seven (7) batches of vidas pct including the customer¿s lot 1008722440.The analysis showed that the sample comply with the specifications and vidas pct ref.30450 lot 1008722440 mentioned by the customer is in the trend compared to the other lots.2.2.Tests performed the complaints laboratory tested three (3) internal samples with a respective target at 0.30, 0.87 and 10.90 ng/ml were tested on the retained kit of customer's lot.All the results obtained were within specifications compared to those observed before the batch release.No evolution of the activity of vidas pct ref.30450 lot 1008722440 was observed over time.The complaints laboratory subscribes to different external quality assessment program and tests those quality control samples such as an ordinary user.For this investigation, the complaints laboratory tested two samples from cap survey (us program) and one sample from probioqual (french program) with vidas pct ref.30450 lot 1008722440.Cap02 cap survey specification range [6.49-8.80] ng/ml with vidas pct lot 1008538020 cap02 = 7.92 ng/ml; with vidas pct lot 1008722440 cap02 = 7.52 ng/ml.Cap04 cap survey specification range [5.94-8.01] ng/ml with vidas pct lot 1008687840 cap04 = 7.20 ng/ml; with vidas pct lot 1008722440 cap04 = 6.96 ng/ml.Bg05 probioqual specification range [14.294 ¿ 19.340] ng/ml with vidas pct lot 1008152990 bg05 = 17.14 ng/ml; with vidas pct lot 1008722440 bg05 = 17.11 ng/ml all the external quality controls' results were compliant to the suppliers' specifications (cap survey and probioqual) when testing with vidas pct lot 1008722440 (customer¿s batch).The results obtained on vidas pct ref.30450 lot 1008722440 were not significantly different from the results obtained at the time of the eqa assessments.3.Root cause analysis and conclusion according to the investigation, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on the retain kit vidas pct ref.30450 lot 1008722440 using internal samples and external quality control materials from two different external quality assessment programs.The investigation did not manage to identify any obvious root cause.However, the issue could have a multifactorial root cause combining: the quality control sample processed by the customer (e.G stability, homogenization, and handling).The calibration results a matrix effect of the quality control sample.It is mentioned in the clsi guideline ep14-a3 that processed samples used as qc material (e.G eqa) can have matrix effect.¿current scientific data suggest that such use of pt/ eqa results is not always feasible because of matrix effects.These processed materials us as pt/ eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples¿.According to investigation outcomes, there is no reconsideration of the performance of vidas pct ref 30450 lot 1008722440 to its expectations.

• Brand Name: VIDAS® BRAHMS PROCALCITONIN
• Type of Device: VIDAS® BRAHMS PROCALCITONIN
• 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: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 13061520
• MDR Text Key: 290271156
• Report Number: 8020790-2021-00393
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Catalogue Number: 30450
• Device Lot Number: 1008722440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1