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

Note: reference 30405 is not registered in the united states.The u.S.Similar device is product reference 30405-01 a customer in germany notified biomérieux obtaining an out of range high results in association with the vidas® hcg 60 tests (ref 30405, lot 1007820580) when testing an instand eqa sample.The customer tested the sample in duplicate using lot 1007820580; the specified range and customer results are listed below: sample 32 - expected range = 36268 ¿ 67354 mui/ml result 1: 77709 mui/ml ¿ result is out of range high result 2: 73226 mui/ml ¿ result is out of range high the customer stated the sample was tested like a patient sample: with a dilution series of 1:10, then tested with a dilution equivalent to 1:100, using r1 diluent.Biomerieux requested the customer performed a qcv test; this information has not yet been provided.As there is no patient associated with this eqa strain, there is no adverse event related to any patient's state of health.Biomerieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in germany regarding an out-of-range-high result in association with the vidas® hcg 60 tests (ref (b)(4), lot 1007820580) when testing an instand eqa sample.The customer¿s samples were requested for the investigation; however, the samples were not available for submission.No anomalies were identified during the manufacturing, control, or packaging processes for vidas® hcg lot 1007820580/210102-0.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 (b)(4) including the customer¿s lot 1007820580/210102-0.The analysis showed all results were within specifications, and the customer¿s lot was in trend of the other lots.Testing of internal samples with vidas® hcg 1007820580/210102-0 retain kit obtained results within specification.The results were similar compared to those obtained before the batch release.The complaint laboratory tested external quality control probioqual on retain kit vidas® hcg 1007820580/210102-0, and also obtained results within expected ranges.In the absence of the instand samples submission by the customer, 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 had 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 (b)(4), lot 1007820580/210102-0.See section h10.

• 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: 10997930
• MDR Text Key: 222038456
• Report Number: 8020790-2020-00133
• Device Sequence Number: 1
• Product Code: DHA
• 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: 01/26/2021

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: 01/02/2021
• Device Catalogue Number: 30405
• Device Lot Number: 1007820580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1