MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® MEASLES IGG

Model Number 30219

Device Problem False Negative Result (1225)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer from (b)(6) notified biomérieux of false negative patient results in association with the vidas® measles igg assay.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).Once the assay is completed, results are analyzed automatically by the computer.Fluorescence is measured twice in the reagent strip's reading cuvette for each sample tested.The first reading is a background reading of the substrate cuvette before the spr is introduced into the substrate.The second reading is taken after incubating the substrate with the enzyme remaining on the interior of the spr.The rfv (relative fluorescence value) is calculated by subtracting the background reading from the final result.This calculation appears on the result sheet.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: (b)(6).On the (b)(6) 2019, a customer in the (b)(6) reported to biomérieux that they have obtained false negative results associated with the vidas measles igg assay (ref 30219, lot 1007326210).In (b)(6) 2019, a measles patient had been tested and the result was negative.This result was unexpected, so the patient was tested again via two (2) testing methods in (b)(6) 2019: with vidas: negative result (msg test value = 0.3).With liason xl (chemiluminescence assay): positive result [msg test value = 26 au/ml (>16.65)].The customer reported that the sample was tested again on the vidas multiple times and the results were again negative (msg values not provided).Then as the clinical presentation didn't fit with negative result, the sample was sent to a reference laboratory: with liason xl (chemiluminescence assay): positive result (msg value not provided).Finally, the customer sent the sample to an additional laboratory: with roche cobas instrument: positive result (msg value not provided).In summary, the vidas measles igg assay continually provided negative results, while other forms of testing yielded positive results.The customer reported that the patient was harmed (inappropriate treatment); the patient was given an unnecessary measles vaccine.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united kingdom regarding false negative patient results in association with the vidas® measles igg assay (reference#: (b)(4), lot#:1007326210).The customer reported that the patient was harmed (inappropriate treatment); the patient was given an unnecessary measles vaccine.A biomérieux internal investigation has been completed with the following results: complaint trending analysis: the only complaint for sensitivity issue on vidas measles igg batch#: 1007326210/ 200320-0 is the one from this customer.Only two (2) complaints for sensitivity issue on vidas measles igg batches: 1007326210 / 200320-0 and 1007432430 / 200512-0.These two (2) complaints are the ones from this customer.There is neither capa nor non conformity linked to the object of this issue.Analysis of control charts: analysis of five (5) internal sample from activity panel was carried out on eight (8) lots of vidas msg including the customer's lot: 1007326210 / 200320-0.Vidas msg lot: 200320-0 has a trend to give lower results compared to other lots.Tests performed internally: on internal samples.Five (5) positive samples with a positive target were selected according to their weak indexes and two (2) of them had a target just above the positive threshold.They were tested on the vidas measles igg batch mentioned by the customer 1007326210 / 200320-0 from retain kits.The five (5) samples were within their acceptable range; no global evolution was observed over time.On customer's samples: the negative results observed by the customer on the vidas measles igg batch mentioned by the customer were reproduced.According to the investigation conducted by the industrialization and support team, including tests performed on additional samples from internal biobank, there is no reconsideration of the between lot variability of vidas measles igg assay ref.30219 which is still in accordance with the precision profile of vidas measles parameter.Conclusion: although the negative results were reproduced on some samples (e.G customer's samples) and some differences of test values were observed, there is no reconsideration of vidas measles igg assay performances.According to all the data issued during the both investigations, there is no reconsideration of the vidas measles igg lot.Moreover, no uprising trend of complaints was observed on this lot mentioned by the customer.Consequently, and in accordance with the information mentioned above, vidas measles igg lot: 1007326210 / 200320-0 was still within specifications.

• Brand Name: VIDAS® MEASLES IGG
• Type of Device: VIDAS® MEASLES IGG
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile, 69280 ; FR 69280
• MDR Report Key: 9224266
• MDR Text Key: 163735051
• Report Number: 8020790-2019-00062
• Device Sequence Number: 1
• Product Code: LJB
• UDI-Device Identifier: 03573026064532
• UDI-Public: 03573026064532
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: 30219
• Device Catalogue Number: 30219
• Device Lot Number: 1007326210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other