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 that they observed out of range high results when using vidas® hcg 60 tests (ref.30405, lot 1008107910), in the context of an external quality control.As this was an external quality control sample, there is no patient involved.The customer obtained the following results when testing the liquichek immunoassay plus control bio-rad, level 1 with vidas hcg 60 tests, lot 1008107910: on (b)(6) 2020: 5.39 mui/ml.On (b)(6) 2020: 5.55 mui/ml, 6.29 mui/ml, 6.07 mui/ml, 5.35 mui/ml, 6.02 mui/ml.On (b)(6) 2020: 5.13 mui/ml.The expected range for this qc sample level 1 was 4.23 (3.51 - 4.949) rilibäk range (17% deviation).It is reported that calibrations performed on (b)(6) 2020 and on (b)(6) 2020 were valid.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).

• Brand Name: VIDAS HCG
• Type of Device: VIDAS® HCG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10907491
• MDR Text Key: 252878013
• Report Number: 8020790-2020-00127
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Catalogue Number: 30405
• Device Lot Number: 1008107910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1