MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® B·R·A·H·M·S PCT¿; VIDAS BRAHMS PROCALCITONIN 60T - 30450-01

Model Number 30450-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of falsely underestimated procalcitonin (pct) results in association with the vidas® brahms procalcitonin 60t (ref 30450-01, lot 1007479440).The results were as follows: pct initial result = 0.07 ng/ml; pct repeat result = 0.98 ng/ml.The customer suspected that the initial results were abnormally low, since the patient was being tracked for pct over time.There is no indication or report from the laboratory that the falsely underestimated pct results led to any adverse events related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of falsely underestimated procalcitonin (pct) results in association with the vidas® brahms procalcitonin 60t (ref 30450-01, lot 1007479440) regarding two samples from two different patients.The customer also stated that they ran controls and a qcv which failed for position a-1.Qcv lot number used : 1007342130.Tv1 expected value = 5.7.Tv1 failed values is 3.13 in a1.In all other position tv1 as expected.The r3 value must be higher than 4100.R3 failed values is 1552 in a1, in all other position r3 as expected.The customer was instructed to perform a retrospective analysis to determine if any other patient samples may have been impacted.No other samples were found to be impacted.A qcv failure is not an abnormal behavior.This control is meant to detect residual risks, that are rare and sudden.Those risks are already present and accepted into the vidas system risk analysis.A field service engineer (fse) visited the customer's site and determined that the qcv detected failure was due to a clogged pump for position a1.The fse performed the following actions: pump replacement, check spr block and adjustment, check tower height and adjustment, leak test and qcv test.The tv1 and r3 result values were correct on all positions.The instrument is again fully functional.

• Brand Name: VIDAS® B·R·A·H·M·S PCT¿
• Type of Device: VIDAS BRAHMS PROCALCITONIN 60T - 30450-01
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9654006
• MDR Text Key: 177267004
• Report Number: 8020790-2020-00013
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1007479440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1