MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® MEASLES IGG 60TESTS

Model Number 30219

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Product description.Vidas® measles igg (msg) is an automated qualitative test for use on the instruments of the vidas family, for the detection of igg antibodies to measles (rubeola) virus in human serum using the elfa technique (enzyme linked fluorescent assay).A test value is generated for each sample by forming a ratio from the rfv of the sample to that of a standard.Test values from patient and control samples are compared to a set of thresholds stored in the computer representing a low measles antibody titer.The following table shows the thresholds and the interpreted results.Test value interpretation 0.50 negative.0.50 to < 0.70 equivocal.0.70 positive.Issue description.On (b)(6) 2021, a customer from australia reported to biomérieux that he obtained an equivocal result and a false negative result when testing external quality control with vidas measles igg 60tests (b)(4).30219, batch number: 1008890110, expiry date: 16 jun 2022.The customer tested a quality control sample during a challenge managed by rcpaqap program; he obtained the following results: sample id: se-me-22-01.Customer reported an equivocal result (0.61 tv).To be noted, according to the ifu, an equivocal result is not considered as negative nor as weak positive, it is a non-status result.Sample id: se-me-22-02.Customer reported a negative result (044 tv) but the sample was not assessed because of the high variability of results observed with the different methods.Calibration was done and was valid.As it is an external quality control, there is no data to suggest a potential patient¿s impact of this issue, or any delayed results.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in australia that they obtained an equivocal result and a false negative result when testing external quality control with vidas measles igg 60tests (ref.30219, batch number 1008890110).Investigation: customer sample no material received from the customers.Complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.Control chart analysis: control chart analysis was carried out on four (4) internal samples (respective target at 0.94 / 0.98/ 0.99 and 1.41 tv) using seven (7) batches of vidas measles igg ref.30219 (including the customer¿s lot).All results were within specifications and results for the customer¿s lot was consistent with the results of the other lots.Internal sample testing: the complaints laboratory tested different internal samples (a negative sample and two positive samples including one with a weak reactivity) on the retain kit of vidas measles igg lot mentioned by the customer (1008890110) compared to another batch selected as a reference (lot 1009035960).Results complied with the specifications without any significant difference compared to those observed before the batch release.Biomérieux did not observe any evolution over time of these samples activity.Moreover, there is no significant difference of results between the different lots.Analysis of quality control sample program: the complaints laboratory subscribes to different challenges of external quality assessment program from uk neqas as an ordinary laboratory.According to the outcomes analysis of the program named measles and mumps igg serology, the results of the different samples expected positive were in accordance with the expectations except for one sample which was not scored because of the distribution observed.Conclusion: the complaints laboratory did not reproduce the issue reported by the customers when testing internal samples on vidas measles igg ref.30219 lot 1008890110.The results obtained were comparable to those obtained with another lot without significant evolution over time.Without the customer¿s material available, it is not possible to pursue further the investigation and we did not manage to identify any obvious root cause.For reminder, it is mentioned in the clsi guideline ep14-a3 that processed samples used as qc material (e.G eqa) can have matrix effect.¿current scientific data suggest that such use of pt/ eqa results is not always feasible because of matrix effects.These processed materials us as pt/ eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples¿.The concerned customer reported equivocal results which are not considered as weak positive or high negative results.Indeed, it is mentioned in the package insert of vidas igg test ref.30219 lot 1008890110.The following information: "the imprecision inherent in any method implies a lack of confidence in samples with test values very close to the thresholds.Consequently, an equivocal zone is established between the thresholds based on a statistical understanding of this imprecision.Equivocal samples should be repeated with a fresh specimen.If it is impractical to obtain a fresh specimen, repeat the assay with the original specimen (provided it is not microbially contaminated, lipemic, or hemolyzed).If the sample repeats as an equivocal, test it using another method".According to the data mentioned above, there is no reconsideration of vidas measles igg ref.30219 lot 1008890110.

• Brand Name: VIDAS® MEASLES IGG 60TESTS
• Type of Device: VIDAS® MEASLES IGG 60TESTS
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14518928
• MDR Text Key: 300047903
• Report Number: 8020790-2022-00066
• Device Sequence Number: 1
• Product Code: LJB
• UDI-Device Identifier: 03573026064532
• UDI-Public: 03573026064532
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: 30219
• Device Catalogue Number: 30219
• Device Lot Number: 1008890110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1