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

Catalog Number 30450

Device Problem False Positive Result (1227)

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

Event Date 02/05/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a customer contacted biomérieux france subsidiary to report a false positive result obtained with vidas® brahms procalcitonin (pct) ref.30450 lot 1003549050 (expiration date 22-oct-2015).The patient was tested (b)(6) 2014 with vidas® brahms pct, lot 1003549050.The result was positive at 15.63 ng/ml indicating a high risk of severe sepsis and/or septic shock.Based on the sample result and patient's clinical status, the clinician performed a lumbar puncture to confirm or exclude meningitis infection.In conjunction with the lumbar puncture procedure, the clinician collected another sample (collected at 1:00pm) for testing; the result of this test was negative at 0.28 ng/ml.A second aliquot of the first sample was retested with vidas brahms pct and the result was negative (0.36 and 0.34 ng/ml).No further information has been provided regarding the clinical status of the patient or the reason to take the decision of performing the lumbar puncture.Internal biomérieux investigation has been initiated.As the sample for which the false positive result was reported is no longer available, the investigation will include a review of the batch file and complaint history records.This file will be updated as further information becomes available.

Manufacturer Narrative

Device not returned to manufacturer.

Manufacturer Narrative

Review of the batch record confirmed no abnormalities were associated with vidas pct lot 1003549050.Review of complaint records reveals one customer complaint against the associated lot.There have been no corrective and preventive action (capa) files initiated against vidas pct assay.There have been no non-conforming material reports (ncmr) initiated against vidas pct assay.There is no evidence of non-conformity or manufacturing test failure associated with vidas pct lot 1003549050.The root cause of the customer's initial false-high pct result cannot be determined (neither the device nor the patient sample was submitted for evaluation).

• Brand Name: VIDAS BRAHMS PROCALCITONIN 60T
• Type of Device: VIDAS BRAHMS PCT
• Manufacturer (Section D): BIOMÉRIEUX SA; 376, chemin de l'orme; marcy l'etoile, fr 6928 0; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376, chemin de l'orme; marcy l' etoile, fr 6928 0; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4518586
• MDR Text Key: 5440544
• Report Number: 3002769706-2015-00002
• Device Sequence Number: 1
• Product Code: NTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2015
• Device Catalogue Number: 30450
• Device Lot Number: 1003549050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 02/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR