MAUDE Adverse Event Report: BIOMERIEUX,SA VIDAS® HCG

Catalog Number 30405

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a false positive result, as part of an external quality assessment from (b)(4), when using vidas® hcg (ref.30405); lot 1006186670.For sample #31, the customer obtained a higher result than expected of 85,900.05 mui/ml.The expected result for sample 31 was 65,970 mui/ml, within the range [46,179 - 85,761].A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed due to a false positive result for external quality assessment (eqa) samples 31 and 32, group 306 (instand) for vidas® hcg (ref.30405) lot 1006186670.Samples were submitted by the customer fro evaluation: 1) instand rv 2018 nr 306 schwangerschaft 2 trimester probe 32.2) instand rv 2018 nr 306 schwangerschaft 2 trimester probe 31.A review of quality records confirmed: no other complaints on this batch 1006186670/181208-0 no capa nor non-conformity linked to the customer's issue.A review of the batch history record confirmed there was no anomaly during the manufacturing, control and packaging processes.The control cards were conforming and batch 1006186670/181208-0 gave results in the trend of other lots.(b)(4).-eqa 31 and 32 were tested after dilution 1:100 in the r1 (included in the box) and gave results close to those expected or higher.Sample 31: target 65970 u/l (46179-85761).Sample 32: target 15227 u/l (10659-19795).Testing did not reproduce the low results obtained by the customer.Conclusion: customer's anomaly was not reproduced in-house.It is likely that the customer made a mistake performing the dilution (no dilution was indicated in the minividas software).Interpretation of the results is conforming to the expected results.Per instand, for group 306 all participants are evaluated together.The eqa expert evaluates all results together because the comparability of all methods leads to valid results.The target value for hcg intact is the robust mean (algorithm a according to din iso 13528, annex c).In this eqa (306) , the number of vidas users is very low.The values of group 306 are higher, because the eqa refers to the hormones - gravidity - 2nd trimester screening.The vidas hcg, ref.30405, lot 181208-0 is within expected specifications.

• Brand Name: VIDAS® HCG
• Type of Device: VIDAS® HCG
• Manufacturer (Section D): BIOMERIEUX,SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• MDR Report Key: 7818413
• MDR Text Key: 118752450
• Report Number: 3002769706-2018-00162
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2018
• Device Catalogue Number: 30405
• Device Lot Number: 1006186670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1