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 (b)(6) notified biomérieux obtaining an out of range high results in association with the vidas® hcg 60 tests (ref 30405, lot 1007173740) when testing eqa sample ¿a¿.The customer tested sample ¿a¿ using lot 1007173740 and obtained a result of 68631 u/l; the specified range for sample ¿a¿ was 34000-63400 u/l.The customer stated the samples were 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 perform 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 1007173740) when testing eqa sample ¿a¿.An analysis of batch vidas® hcg 1007173740 / 200213-0 quality data was performed.No anomalies related to the customer¿s complaint were found during the manufacturing, quality control, or packaging stages on the batch.The complaints laboratory could not carry out tests on the retain of the impacted lot as the lot had expired in february 2020.A study of internal samples' control charts and eight (8) batches of vidas® hcg, including that of the customer, showed that all results were within specifications.The customer's batch was in the trend of the other batches.A possible cause of the complaint is due to the dilution.The result provided by the customer to rfb is a diluted result.The dilution factors used are not those validated by biomérieux or mentioned in the package insert.The vidas® hcg package insert states the following: ¿samples with hcg concentrations greater than 1,500 miu / ml may be re-assayed after diluting by 1/20 to 1/200 with the hcg diluent (r1).Any dilution that is not between 1/20 and 1/200 has not been validated and is the customer's responsibility.¿.According to the investigation, vidas® hcg reference (b)(4) lot 1007173740 / 200213-0 was within the expected performance at the date of the test.

• 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: 10997985
• MDR Text Key: 248136804
• Report Number: 8020790-2020-00134
• 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: 01/11/2021

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: 02/13/2020
• Device Catalogue Number: 30405
• Device Lot Number: 1007173740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1