MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TSH3 ASSAY

Model Number 30441

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining a false low result in association with the vidas® tsh3 assay (reference 30441, lot 1006905220).The customer stated they obtained a result of 1.93 uiu/ ml (normal range 0.27-4.70).The customer also tested the sample using vitros® yielding a result of 7.96 uiu/ ml (normal range 0.465 - 4.68) and cobas ® yielding a result of 8.82 uiu/ m (normal range 0.270 - 4.20).Though vidas® tsh3 assay (reference 30441) is not registered, marketed or distributed in the u.S., a similar product vidas® tsh (reference 30400-01) is registered in the u.S.There is no indication or report from the laboratory or physician that this incident have led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated for a customer report of a false low result in association with the vidas® tsh3 assay (reference 30441, lot 1006905220).The customer's sample was not available to submit for the investigation.The investigation included a trend analysis, a review of quality control records, a study of control charts for internal samples, and testing of internal samples with retained kits of the customer's impacted lot.Additionally, the customer provided further testing data on the sample.Investigation results: complaint trending analysis: the trend analysis showed no recurrence of the customer's anomaly.Quality control records: the batch history records showed no anomaly during the manufacturing, control and packaging processes.No non-conformity and no capa was linked to the customer's complaint recorded on vidas tsh3 (ref 30441).Study of internal samples control charts: this analysis was carried out: on three internal hypothyroidism sera with different concentrations (target: 7.02 ui/ml, 14.6 ui/ml, and 25.6 ui/ml).On seven vidas tsh3 batches including the batch mentioned by the customer (1006905220/191021-0).All the results were within specifications.Vidas tsh3 lot 1006905220/191021-0 was in the trend compared to the other batches.Test performed by complaint laboratory: the internal laboratory performed a calibration with three internal hypothyroidism tsh serums on the retained kit vidas tsh3 lot 1006905220/191021-0: all results were within their specifications and similar to those obtained during the process of control of the lot.There was no drift of the batch since its release.Tests performed by the customer: test performed by the customer on hbt tube (heterophilic blocking tube) gave higher results in vidas tsh3 (9.253 ui / ml) and also in vitros (13 ui/ml).Results showed that there was an interference due to heterophilic antibodies.Conclusion: according to all information above, the main probable root cause to customer's issue is an interference due to heterophilic antibodies present in the patient sample.These interferences are rare in vidas tsh3 but can be encountered sometimes as indicated in the package insert of vidas tsh3: limitations of the method: interference may be encountered with certain sera containing antibodies directed against reagent components.The results of a tsh3 assay must be interpreted as part of a complete clinical profile.In case of discrepancy, this assessment must be completed by thyroid hormone measurement.The investigation concluded that vidas tsh3 ref.30441, lot 1006905220 / 191021-0, is within the expected performances.

• Brand Name: VIDAS® TSH3 ASSAY
• Type of Device: VIDAS® TSH3 ASSAY
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 9142194
• MDR Text Key: 219786476
• Report Number: 8020790-2019-00057
• 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: 12/17/2019

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 Model Number: 30441
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 11/18/2018
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1