MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA AGAR

Catalog Number 43459

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomérieux to report the occurrence of a false positive result in association with chromid® mrsa agar (reference 43459, lot 1006377250).The false positive results were reported by the customer to biomérieux on (b)(6) 2018.The product expiration was june 5, 2018.The customer stated there was a delay of three (3) days due the need for retesting of the specimen.The customer indicated there was no incorrect result reported to the treating physician, and there was no adverse impact to the patient's state of health due to the discrepant chromid mrsa results.Although product reference 43459 is not sold/registered in the united states, a similar product (reference 43451 - chromid mrsa agar) is sold in the united states.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in denmark contacted biomérieux to report the occurrence of a false positive result in association with chromid® mrsa agar (reference 43459, lot 1006377250).An investigation was performed.A review of production records confirmed the lot was manufactured in accordance with specifications.The results of microbiological quality control were in accordance with specifications as indicated in the quality certificate.No non-conformities were recorded on this lot number.Retained sample analysis: the impacted batch (1006377250 ) was not available as it expired 05jun2018.Inoculations were performed on 27aug2018, using three (3) other batches, with one close to its expiration date, to make sure the concentration of antibiotic remains until the end of the shelf life.The batches tested are as follows.Retention samples kept at 2-8 º c: * 1006569920 exp 28-08-2018 *1006704310 exp:24-10-2018 fresh sample of chrom id mrsa agar: *1006736620.Exp: 09-11-2018 columbia blood agar was used as the control to make sure that the intended target strain was recovered.Inoculation of mssa negative qc strains used in routine, were performed following the qc standard procedure.The strains were: s.Aureus atcc 25923, s.Aureus atcc 29213, s.Aureus 05047605, and s.Aureus 0506614.Readings were performed after incubation under aerobic conditions at 33- 37 º c for 20-28 hours.A second reading was taken up to 48 hours.Following incubation, all mssa strains were perfectly inhibited on all batches tested, including the batch close to expiration, where after 48 hours the lack of growth was well maintained.Therefore, the selectivity was as expected, showing a perfect inhibition as found in the initial qc test.The findings were expected and within acceptance criteria.Complaint trend analysis a review of complaints registered for the impacted reference ( 43451/43459 ) does not show any significant increase of this problem regarding this media.Conclusion the issue observed by the customer was not confirmed.The routine qc strains still perform well, and confirmed the highly specific media perfectly inhibited all mssa strains, not producing false positives.Therefore, the false positives observed by the customer could be linked to media degradation at customer level or strain variability, as it was defined tin the package insert, certain strains of s.Aureus which do not have the mec a gene may develop typical colonies after 24 or 48 hours of incubation.Therefore, for any further investigation, we would need the mssa strain / plates from the customer.According to package insert instructions, the product performed within expected specifications : -sensibility of detection described in the package insert is not stated in any type of sample at 100%, it means it already consider the possible cases of these type of strains, supporting the product risk analysis.

• Brand Name: CHROMID® MRSA AGAR
• Type of Device: CHROMID® MRSA AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5 rue des aqueducs; 69290 craponne; FR
• MDR Report Key: 7677668
• MDR Text Key: 114023982
• Report Number: 3002769706-2018-00105
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K162076
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2018
• Device Catalogue Number: 43459
• Device Lot Number: 1006377250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Patient Sequence Number: 1