MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS HCG; 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) notified biomérieux of obtaining out of range high hcg results for two (2) external quality control (instand) samples in association with the vidas® hcg 60 tests (ref 30405, lot 1007736840).Group: 306 , sample 21: expected result sample 21: 47369 (33158 - 61580) u/l.Customer result for sample 21: 68300 u/l.Group: 306 , sample 22: expected result sample 22: 70955 (49669 - 92242) u/l.Customer result for sample 22: 101595 u/l.As these were external quality control samples, there are no patients involved.A biomérieux internal investigation has been initiated.Note: reference 30405 is not registered in the united states.The u.S similar device is product reference 30405-01 (k141133).

Manufacturer Narrative

This report was initially submitted following notification from a customer in germany regarding out of range high hcg results for two (2) external quality control (instand) samples in association with the vidas® hcg 60 tests (ref 30405, lot 1007736840).The customer¿s samples were requested for the investigation; however, the samples were not available for return.The customer's batch, vidas® hcg batch 1007736840 / 201105-0, was expired at the investigation time; therefore, the complaints laboratory did not perform any tests on it.No anomalies were identified during the manufacturing, control, or packaging processes for vidas® hcg lot 1007736840 / 201105-0.The complaints laboratory analyzed the control chart results of six (6) internal samples with a target within the measurement range of vidas® hcg, on seven (7) different batches of vidas hcg ref 30405 including the customer¿s lot 1007736840 / 201105-0.The analysis showed all results were within specifications, and the customer¿s lot was in trend of the other lots.In the absence of the instand samples return, and the customer¿s vidas® hcg batch expired, it is impossible to pursue further investigations into the root cause of the customer¿s results.It was not possible to check if the dilution may have an impact on the results.Biomérieux never received any information from instand regarding the behavior of the quality control samples after dilution.There is no reconsideration of the performance of vidas® hcg ref 30405 lot 1007736840 / 201105-0.

• Brand Name: VIDAS HCG
• Type of Device: VIDAS® HCG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 10907521
• MDR Text Key: 252620321
• Report Number: 8020790-2020-00126
• Device Sequence Number: 1
• Product Code: JLW
• 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: 01/25/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2020
• Device Catalogue Number: 30405
• Device Lot Number: 1007736840
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1