MAUDE Adverse Event Report: BIOMERIEUX SA 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

Intended use.Vidas cmv igg is an automated quantitative enzyme immunoassay for use on the vidas family instruments for the quantitative measurement, of anti-cytomegalovirus igg (cmvg) in human serum, using the technique elfa (enzyme linked fluorescent assay).Results interpretation: value (au/ml) interpretation; (b)(6).Issue description: on (b)(6) 2021, a customer from (b)(6) reported to biomerieux that they observed (b)(6) results when testing a patient sample from a pregnant woman with vidas® cmv igg 60 tests (ref.(b)(4), batch 1008464750, expiry date 03-nov-2021) compared to another method (diasorin method).The woman does not have any particular disease and is not taking any drugs.This customer usually uses the diasorin method and vidas® 3 just for confirmation of (b)(6) results.In the past this woman was always (b)(6) but in this case the customer got (b)(6) result with diasorin and (b)(6) with vidas® 3 (serial # (b)(4)).The sample was repeated twice on the vidas® 3 but the results were the same.There was no delay in reporting results and the (b)(6) results from the diasorin method were reported.Therefore, no wrong results were reported.Summary: vidas® 3 : (b)(6).Diasorin: (b)(6) and (b)(6).The sample is no longer available because this issue happened a month and half ago.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux 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 italy that they obtained a false negative routine sample for one (1) patient sample in association with vidas® cmv igg (ref 30204 lot 1008464750).Investigation device history record and complaint analysis the analysis of the batch history record for the vidas cmv igg ref 30204 lot 1008464750 showed no anomaly during the manufacturing, control and packaging processes.No non-conformity nor capa is linked to the customer¿s complaint recorded on vidas cmv igg ref 30204 lot 1008464750.Complaints from 01dec2020 to 07dec2021 were reviewed, and biomérieux received no other complaints against vidas cmv igg ref 30204 lot 1008464750 for false negative routine sample.The customer's sample is not available for investigation.Control charts the complaints laboratory analyzed 4 internal samples (targets <4 ¿ 30.4 ¿ 44.4 and 11.1 ua/ml), on 7 batches including the lot mentioned by the customer.All values are within specifications, customer¿s lot is consistent with the other lots.Without the customer¿s return sample and as vidas cmv igg ref 30204 lot 1008464750 is expired, it is difficult to perform further analysis to determine the root cause.Conclusion the root cause of the reported issue has not been identified.The customer was unable to return the patient sample for the investigation, and vidas cmv igg ref 30204 lot 1008464750 was expired at the time of the investigation.Therefore, further investigation cannot be pursued.According to the investigation above, vidas cmv igg ref 30204 lot 1008464750 is still within expected performance.

• 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
• Manufacturer (Section G): BIOMERIEUX 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: 12924759
• MDR Text Key: 290279314
• Report Number: 8020790-2021-00336
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K920661
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Catalogue Number: 30204
• Device Lot Number: 1008464750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female