MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS CMV IGG; VIDAS® CMV IGG

Catalog Number 30204

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

On (b)(6) 2021, a customer from (b)(6) reported to biomerieux that they observed false negative results when testing patient samples with vidas cmv igg 60 tests (ref.(b)(4), batch 1008370850, expiry date = 10-sep-2021) compared to another method (ifi: indirect immunofluorescence).The customer reported that during the last 2 months, they have been using batch 1008370850 of vidas cmv igg 60 tests and they¿ve observed more negative results from adults, kids and pregnant patients than they expected.Discrepant results were reported for four patients: a (b)(6) pregnant woman, a (b)(6) patient with adenopathy, a (b)(6) patient with fever and a (b)(6) patient with arthritis.For all four patients the results were the following: result with vidas cmv igg 60 tests batch 1008370850: negative (<4).Result with immunofluorescence (ifi) technique: positive (after 1/64 dilution of the sample).The patient samples were serum collected in plastic and disposable tubes.All patients were negative for cmv igm when tested with vidas cmv igm 30 tests (ref.(b)(4), batch number not reported).The results which were communicated to the patients were the positive cmv igg results obtained with the ifi technique.Calibration of vidas cmv igg 60 tests batch 1008370850 was performed on (b)(6) 2021 and was valid but homogenization steps were performed manually and not using a vortex.It was reported that qcv was performed on (b)(6) 2021 and was conform and that last preventive maintenance was performed on (b)(6) 2020.As a consequence of these false negative results, a delay of results of 24 hours occurred.There was no impact on patient treatment or state of health.According to the package insert for the ifi technique, the following limitations for interpretation of results are listed: a single serological igg antibody titer to cmv should not be used as the only criterion for diagnosis.Paired serum samples (acute and convalescent) and testing for igm specific cmv antibodies may provide more meaningful data.Test results on specimens from immunosuppressed patients and pregnant women may be difficult to interpret.Positive test results may not be valid in persons who have received blood transfusions or various blood products within the past several months.Antinuclear antibodies present in serum may interfere with the cmv ifa test.A biomerieux internal investigation will be initiated.Note: reference (b)(4) is not registered in the united states.The u.S.Similar device is product reference (b)(4).

Manufacturer Narrative

An internal investigation was performed following notification from a customer in argentina of observing false negative results when testing patient samples with vidas cmv igg 60 tests (ref.30204, batch 1008370850, expiry date = 10-sep-2021) compared to another method (ifi: indirect immunofluorescence, ie mbl bion cytomegalovirus antigen substrate slide.).Investigation: 1.Device history record review.The review did not highlight any issue during manufacturing for vidas cmv igg lot 1008370850.2.Tests/analysis performed.The samples involved were not available for investigation, so tests were performed on internal samples and external quality controls available at complaint laboratory.Control chart analysis: the complaints laboratory analyzed four internal samples including one negative and three positive (with one positive close to the cut off targeted at 11.1 ua/ml) with seven different batches of vidas cmv igg including lot 1008370850 mentioned by the customer.The analysis of the control charts showed that all results are within specifications and the customer¿s lot is consistent with the other lots.Tests performed by complaints laboratory: two internal samples were then tested - including one negative and one positive close to the positive cut off (targeted at 11.1 ua/ml) - using retained kit of the customer¿s lot.All the results are within specifications and similar to the results obtained before the batch released.Lastly, the retained samples were used to test two positive external quality control samples (ctcb 2115 = 44 ua/ml and ctcb 2125 = 7 ua/ml).All the results are within specifications and consistent with peer group specifications.Root cause: according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on the retain kit vidas cmv igg lot 1008370850 using internal samples and external quality controls (from ctcb) materials.According to the mbl bion cytomegalovirus antigen substrate slide package insert (competitor kit used by customer), there are limitations of the procedure in term of clinical and analytical interpretation.The following items are mentioned in particular that may have an impact on the positive interpretation obtained by the customer: ¿2.A single serological igg antibody titer to cmv should not be used as the only criterion for diagnosis.Paired serum samples (acute and convalescent) and testing for igm specific cmv antibodies may provide more meaningful data.- 6.Test results on specimens from immunosuppressed patients and pregnant women may be difficult to interpret.7.Positive test results may not be valid in persons who have received blood transfusions or various blood products within the past several months.8.Antinuclear antibodies (ana) present in serum may interfere with the cmv ifa test.They can be differentiated from cmv staining in that anas stain the nuclei in all cells; whereas, cmv antibodies exhibit nuclear inclusion staining in an average of only five to fifteen cells per 200x field.24 9.Cytoplasmic fluorescence in the majority of the cells may be due to the presence of antimitochondrial antibodies (ama) often seen in primary biliary cirrhosis.They can be differentiated from the specific antigen staining in that ama will stain the cytoplasm of all cells; whereas, cmv antibodies exhibit staining in only an average of five to fifteen cells per 200x field.11.Endpoint reactions may vary between laboratories due to differences in type or condition of fluorescence microscope employed, diluting apparatus, igg/igm separation methods, as well as the experience level of personnel performing the assay.13.Cell culture substrate slides may exhibit nonspecific fluorescence due to contamination of antibodies or pbs rinse-wash solutions with bacteria or fungi.It is very important that personnel reading the staining results have experience in fluorescence microscopy additionally, the customer homogenizes the calibration reagents without vortexing.The investigation did not identify a root cause.Without customer¿s return sample and kit, further investigation cannot be pursued.According to the investigation, the vidas cmv igg 1008370850 lot still meets its specifications.

• Brand Name: VIDAS CMV IGG
• Type of Device: VIDAS® CMV IGG
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 12185446
• MDR Text Key: 281992028
• Report Number: 8020790-2021-00168
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• PMA/PMN Number: K920661
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: 30204
• Device Lot Number: 1008370850
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR