MAUDE Adverse Event Report: BIOMERIEUX, SA VIDAS CD A/B; VIDAS® CD A/B

Catalog Number 30118

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

A biom¿rieux internal investigation has been completed with the following results: a review of the device history record did not highlight any issue during manufacturing vidas¿ cd a/b (ref.(b)(4) lot 1008483190/211126-0).There was no customer sample received for investigation.The complaint laboratory analyzed the results of six (6) internal samples (targets 0.02  5.12  0.06  0.03  2.12 and 0.03 tv) on 6 different batches of vidas¿ cd a/b including customers lot (1008483190 / 211126-0).The analysis of the control charts showed that all results were within specifications and the customers lot was in the trend of the other lots.The complaint laboratory tested three (3) internal samples (targets 5.24  0.05 and 2.59 tv) with the retain kit vidas¿ cd a/b (lot 1008483190/211126-0).All sample results were within their expected specifications.There was no drift of the batch mentioned by the customer since the batch release.The root cause has not been identified and without the customer's sample no further investigation can be performed.According to the investigation results, vidas¿ cd a/b (lot 1008483190/211126-0) is still within expected performance.Per the limitations of the method section in the package insert, "a negative vidas¿ c.Difficile toxin a & b result alone may not rule out the possibility of c difficile-associated colitis or diarrhea.It could be the result of inadequate sampling, handling or sample storage.Always evaluate vidas¿ c.Difficile toxin a & b assay results along with clinical signs and patient history when diagnosing c.Difficile-related disease." note: reference # (b)(4) is not registered in the united states.The u.S.Similar is product reference # (b)(4).

Event Description

A customer in (b)(6) notified biom¿rieux of obtaining a false negative result when testing a patient sample on (b)(6) 2021 with the product vidas¿ cd a/b 60 tests (ref.(b)(4), batch1008483190, expiry date 26-nov-2021).On (b)(6) 2021, a (b)(6) year-old patient was admitted to the intensive care unit for pseudomonas infection and showed dysentery.He was tested with vidas¿ cd a/b 60 tests and found positive; metronidazole therapy was then started.On (b)(6) 2021, a new test on vidas¿ cd a/b 60 tests was performed, and the result was negative so therapy was stopped.The dysentery symptoms came back 10 days later so the vidas¿ cd a/b 60 tests was repeated on (b)(6) 2021 and result was negative.The customer sent the sample to another laboratory for testing (chemiluminescence method was used but brand was not reported) and the result was positive.Metronidazole therapy was restarted and the patient was feeling well two (2) days later.On (b)(6) 2021, a new test was performed using vidas¿ cd a/b 60 tests in parallel with another method (chemiluminescence) and both showed negative results.It is reported that during all this time, the patient never stopped taking meropenem to solve the pseudomonas infection.The customer reported that there was no patient harm or incorrect treatment due to the discrepant result.Metronidazole therapy was started based on the other laboratory's positive result.It is understood that all the tests were performed on vidas¿ cd a/b 60 tests lot#: 1008483190.

• Brand Name: VIDAS CD A/B
• Type of Device: VIDAS® CD A/B
• 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11749944
• MDR Text Key: 250426058
• Report Number: 8020790-2021-00114
• Device Sequence Number: 1
• Product Code: LLH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K080931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Catalogue Number: 30118
• Device Lot Number: 1008483190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR