MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID MRSA AGAR

Catalog Number 43459

Device Problem False Positive Result (1227)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported false positive results reported to the physician in association with the chromid[tm] (b)(6) agar (ref.43459, lot 1004036590, expiry 13aug15).The patient strains produced green colonies typical of (b)(6) organisms.The laboratory performed confirmatory tests of (b)(6) and cefoxitin; the strains were (b)(6) and the cefoxitin screening was negative.After 48 hours, the laboratory informed the physician the strains are not (b)(6).Storage and use are performed in accordance with product specifications.There is no indication or report from the hospital or treating physician to (b)(4) that the discrepant result led to any adverse event related to the patient's state of health.(b)(4) requested patient isolates from the customer for internal investigation.

Manufacturer Narrative

Biomérieux internal investigation was conducted in response to a customer report that the chromid (b)(6) tm agar (ref.(b)(4), batch 1004064750) produced false positive results.Review of complaint history indicates no other complaint has been registered for this batch number.The batch review indicates that no discrepancies were detected during the manufacturing and the results of microbiological quality control are in accordance with specifications as indicated in the quality certificate.Investigation testing included the following: test with routinely (b)(6) negative qc strains following the qc standard procedure for batch release: investigation on the incriminated batch (1004064750), in parallel with a random batch of chromid (b)(6) (1004093010), and a batch of tsa agar (1004126980) to ensure that selectivity is attained by the media and not by lack of strain viability.Identification of the customer strains and susceptibility testing to identify if (b)(6) strains are borderline-susceptible to cefoxitin, which could explain growth on the (b)(6) medium.Test with customer's strains following the qc standard procedure for batch release: investigation on the incriminated batch (1004064750), in parallel with the same random batch of chromid (b)(6) (1004093010), and the same batch of tsa agar (1004126980).For the incriminated batch, testing was performed using plates with thermal shock sequence (117 hours at 15-25°c, 8 hours at 35-39°c, 19 hours at 15-25°c) and plates without thermal shock sequence.The following results were observed: no growth for (b)(6) negative qc strains, in accordance with the expected specifications.2for the four strains provided by the customer, the identification gave staphylococcus aureus.Furthermore, the susceptibility testing confirmed the strains were cefoxitin negative.No growth for customer's strains after 24 hours of incubation for the plates with or without thermal shock sequence.After 48 hours of incubation, biomérieux observed a low growth of some colonies on the plates without thermal shock for two strains.The colonies are uncolored or with typical green color, especially for one strain.For the plates with thermal shock, biomérieux observed growth for three customer's strains after 48 hours of incubation with typical green color colonies.The investigation confirmed that the issue observed by the customer is not related to any defect of the performance of the chromid (b)(6) agar with batch number 1004064750.All clinical strains from the customer were not recovered after 24 hours of incubation on plates with or without thermal shock, not producing false positive reaction on chromogenic medium.The thermal shock sequence performed on our retained samples shows that the antibiotics mixture partially lost its activity whatever the batch used (incriminated batch or reference batch).The growth of the colonies is faster on the plates with thermal shock than the plates without thermal shock.As indicated in the package insert, all characteristic colonies after 48 hours of incubation must be identified.The chromid tm (b)(6) agar is very sensitive to temperature and exposure to light, any deviation from storage/transport requirements prior to use at the customer facility could result in the issue observed by the customer.

• Brand Name: CHROMID MRSA AGAR
• Type of Device: CHROMID MRSA AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4961748
• MDR Text Key: 24654421
• Report Number: 3002769706-2015-00065
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 07/31/2015

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: 08/25/2015
• Device Catalogue Number: 43459
• Device Lot Number: 1004064750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1