MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS TSH; VIDAS® TSH

Catalog Number 30400

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An internal biomerieux investigation was completed.Review of manufacturing device record and quality control data found no anomalies during the manufacturing quality control for packaging of lot 1007920110.Biomerieux tested lot 1007920110 with internal control samples and with the three-biorad samples tested by the customer.All results were within range.The investigation determined lot 1007920110 is performing within specification.

Event Description

Note: reference 30400 is not registered in the united states.The u.S.Similar device is product reference 30400-01.A customer in (b)(6) notified biomerieux of out of range high results in association with the vidas(r) tsh 60 tests (ref.30400 lot 1007920110)when testing two external biorad quality control samples.Sample 1 biorad lyphochek immunoassay plus control ranges are as follows: the expected result was 0.420 uui/ml the expected bio-rad range = 0.203 - 0.637 uui/ml the expected rilibak range (13.5% deviation) = 0.363 - 0.476 uui/ml (b)(6) are the (b)(6) federal medical council guidelines similar to (b)(6).The customer tested sample one (1) six (6) times.One result was above the expected biorad range with a value of 0.82 uui/ml and all results were above the expected rilibak range.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.

• Brand Name: VIDAS TSH
• Type of Device: VIDAS® TSH
• 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: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10945827
• MDR Text Key: 219545182
• Report Number: 8020790-2020-00129
• 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: 12/03/2020

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: 02/17/2021
• Device Catalogue Number: 30400
• Device Lot Number: 1007920110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1