MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® C. DIFFICILE GDH

Catalog Number 30125

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 biomérieux that they observed negative results when testing two patient samples with vidas gdh 60 tests (ref.30125, batch 1008597480, expiry date 18-apr-2022) compared to another method.The customer reported that for two patient samples, the vidas result was negative but the samples tested positive on pcr.The customer tested the first patient who was experiencing diarrhea for 2 weeks using vidas gdh 60 tests batch 1008597480 on (b)(6) 2021 and obtained a negative result (vidas printout not available).Due to positive pcr testing, the test was repeated on another sample using vidas gdh 60 tests batch 1008597480 on (b)(6) 2021.The result was again negative (tv=0).The results were preceded by a valid calibration performed on (b)(6) 2021.There were no further information about the second patient.The customer reported that the patient treatment was delayed due to this discrepant result.There is no information or report from the customer regarding patient harm as a result of this delay a biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following notification from an austrian customer that they observed negative results when testing two patient samples with vidas gdh 60 tests (ref.(b)(4), lot# 1008597480, expiry date 18-apr-2022) compared to another method.Investigation the device history record review did not highlight any issue during manufacturing of vidas gdh ref.(b)(4) lot 1008597480.There are also no capas nor non-conformities against vidas gdh ref.(b)(4) linked to customer 's complaint.There are no other similar complaints recorded against the customer¿s lot number.The customer was unable to submit a portion of their sample to the biomérieux complaint laboratory for testing.Control chart analysis: the complaint laboratory analyzed control charts for thre (3) internal samples (targets 0.01 ¿ 0.27 and 4.27 tv) using five (5) different batches of vidas gdh (including customer¿s lot - 1008597480).All results are within specifications and the customer¿s lot is consistent with the other batches.Internal testing: the complaint laboratory tested four (4) internal samples (targets 0.01 ¿ 0.20 ¿ 0.27 and 4.27 tv) with the retain kit for vidas gdh lot 1008597480.All samples results are within their expected specifications, showing no results drift for the customer¿s lot since the batch was released.The vidas gdh package insert (ref.(b)(4)), documents the following information: "limitations of the method: due to sample heterogeneity, thorough mixing of stool specimens is essential to avoid discrepant results.Samples giving results contradictory to the clinical information available should be retested using a fresh specimen.A negative vidas c.Difficile gdh 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 gdh assay results along with clinical signs and patient history when diagnosing c.Difficile-related disease.Guidelines define the best strategy for c.Difficile testing as testing performed only on diarrheal (unformed) stool, unless an ileus caused by c.Difficile is suspected.The proper specimen for the diagnosis of c.Difficile infection is a watery, loose or unformed stool.Evaluating a formed stool can impact the specificity of diagnosis of cdad.¿ "specimens preparation for the vidas c.Difficile gdh test: semi-solid and solid stools: ¿centrifuge for 10 minutes at 2¿25°c at a minimum of 3000 g¿.Customer¿s samples: native stool in a tube, mushy, homogenization by vortex the centrifugation time was 5 minutes instead of 10 minutes, in an eppendorf-centrifuge with 3000 g.The preanalytical of the sample is critical for vidas gdh.In this case, the centrifugation time is half of the time recommended in the package insert.We cannot exclude the preanalytical cause to explain the wrong result observed.Conclusion: the biomérieux investigation did not identify any obvious 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 gdh lot 1008597480 using internal samples.Due to the date of the first test and the temperature of storage, the stool samples cannot be returned, especially in case of false negative.No further investigation can be pursued without the concerned samples.According to the investigation above, vidas gdh lot 1008597480 is still within expected performance.

• Brand Name: VIDAS® C. DIFFICILE GDH
• Type of Device: VIDAS® C. DIFFICILE GDH
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemine de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12675171
• MDR Text Key: 284287632
• Report Number: 8020790-2021-00196
• Device Sequence Number: 1
• Product Code: MCB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K132010
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Catalogue Number: 30125
• Device Lot Number: 1008597480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1