MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS PROCALCITONIN

Model Number	30450-01
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of observing a calibration issue when using vidas brahms procalcitonin 60t (ref.30450-01, batch number 1008952560, expiry date 26-feb-2023).It was reported that rfu values were high.At the time of this assessment, it is not known whether the high rfv concerned the standard or controls.The customer mentioned a delay in reporting results of one day.The number of involved patients is not known.There is no indication or report from the laboratory that the issue led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following notification from a customer in the united states of observing a calibration issue when using vidas® brahms procalcitonin 60t (ref.30450-01, batch number 1008952560, expiry date 26-feb-2023).Investigation review of the device history record did not highlight any issue during manufacturing, control and packaging processes for vidas brahms pct ref 30450-01 batch 1008952560.There is no capa, no non-conformity on vidas brahms pct (ref 30450-01; batch 1008952560) linked with customer's issue.There has been no other similar complaint registered on vidas brahms pct ref 30450-01, batch 1008952560.Calibration was performed with retained kit vidas brahms pct ref 30450-01 batch 1008952560.S1 = 2615 and 2601 rfv ; range = [1994-3561] rfv.S2 = 541 and 532 rfv ; range = [395-705] rfv.C1 = 18.71 ng/ml ; range = [14.20-22.18] ng/ml.C2 = 2.06 ng/ml ; range = [1.52-2.44] ng/ml.Mean value obtained during the control of the batch : s1 : 2849 rfv.S2 : 564 rfv.C1 : 18,19 ng/l.Calibration conformed to specifications (mle data), and the results are similar to those obtained before the release of the batch.The customer anomaly was not reproduced with retained kit vidas brahms pct (ref 30450-01 batch 1008952560).Conclusion.Customer anomaly was not reproduced with the retain kit and biomérieux testing did not reveal any drift of the results from this lot since its release.A field service engineer )fse visited the customer site and observed that the optics wouldn¿t calibrated properly and they were getting optic 160 errors.The fse changed the scanner board, scanner head and solid standard and calibrated optics.Following these repairs, the fse instrument confirmed issue resolution by running a leak test and qcv.There have been no additional issues since the repair.There is no reconsideration of the performance of the vidas brahms pct ref 30450-01 ,batch 1008952560.

• Brand Name: VIDAS® BRAHMS PROCALCITONIN
• Common Device Name: 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 68280 ; FR 68280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13061720
• Report Number: 8020790-2021-00394
• Device Sequence Number: 1609234
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162827
• 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): 02/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1008952560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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