MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TPSA

Catalog Number 30428

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of discrepant results with the vidas tpsa (reference 30428).The customer reported two (2) different patient results that are lower than results obtained in the past; however, reference lab results were higher than past patient results.The customer reports patient results of 0.22 ng/ml and 0.25 ng/ml utilizing the same batch number and calibration; in addition, the same patient results of <0.07 ng/ml and 1.25 ng/ml were obtained utilizing the same batch number and a different calibration.The customer reports that the samples were sent to a reference lab where one of the patient sample results was about 5 ng/ml.The customer reports that an analysis was made on all positions of the instrument using only one sample of a completely different patient; however, all results were identical.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6)reported vidas® tpsa results are lower than expected for two patients.Biomérieux investigation was conducted.Review of complaint records indicated there is no other complaint for the same issue on the batch vidas tpsa lot 1004597150 / 170106-0.Evaluation of the manufacturing batch record for the referenced lot indicated no anomaly associated with the batch.Investigational testing included four (4) samples processed with vidas® tpsa lot 170160-0; all results were within specification and had not changed since lot release 16-feb-2016.Without customer submittal of the patient samples, no further testing is possible.The performance of vidas® tpsa batch 1004597150 / 170106-0 is within specifications.

• Brand Name: VIDAS® TPSA
• Type of Device: VIDAS® TPSA
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5808579
• MDR Text Key: 49981904
• Report Number: 3002769706-2016-00121
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2017
• Device Catalogue Number: 30428
• Device Lot Number: 1004597150
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1