MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID SALMONELLA AGAR

Catalog Number 43621

Device Problems False Negative Result (1225); Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A clinical customer in (b)(6) contacted biomerieux to report the observation of white colonies on chromid[tm] salmonella agar (ref.(b)(4), lot 1003998840) when the customer was expecting to see the typical pink/mauve colonies indicative of a positive sample.The customer classified this as a false negative result.The negative result was reported to the physician.There is no indication or evidence of patient death or serious injury as a result of the event.The referenced product is for sale in the united states for industry use only, and is not used to test patient samples; however, were the event to recur while testing products for human consumption, contaminated product could be introduced into market.Additionally, similar chromid agar products are sold in the united states for clinical use.Biomerieux has requested the patient isolate for internal investigation.

Manufacturer Narrative

An investigation was conducted using the chromid tm salmonella retained samples of the customer batch (1003998840) in comparison with a random batch of chromid salmonella as reference.Sample strains were the same as those used during release tests.Good growth was observed for all quality control salmonella strains on the customer batch (1003998840) with characteristic pale pink-mauve colonies after 24h of incubation, and dark mauve colonies after 48h of incubation.The same results were observed for the reference batch.In addition, testing was performed with the strain submitted by the customer on the customer batch (1003998840) and on a random batch of chromid salmonella as reference.The same results were observed for the two batches.Good growth was observed for the customer's strain, with uncolored colonies after 24 hours of incubation at 33-37°c and pale mauve colonies after 48 hours of incubation.It was observed that the customer's strain presents a slow growth whatever the chromid salmonella batch used, and therefore the reported issue is not related to any defect with the performance of the chromid salmonella agar ref 43621, lot 1003998840.As indicated in the package insert of this medium, some salmonella serovars may produce a weak coloration or be slow to produce a coloration.The review of complaint records indicates that no other complaint has been registered against this batch number.During the review of the manufacturing and qc batch records, we have identified the following information: this batch (number 1003998840, expiry date: 2015-09-30) was manufactured 13may2015.No discrepancies were detected during the manufacturing of this batch.For the release of the batch after its manufacturing, the results of the microbiological quality control are in accordance with specifications as indicated in the quality certificate.

• Brand Name: CHROMID SALMONELLA AGAR
• Type of Device: CHROMID SALMONELLA AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4957213
• MDR Text Key: 24654713
• Report Number: 3002769706-2015-00062
• Device Sequence Number: 1
• Product Code: JWX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• 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: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 43621
• Device Lot Number: 1003998840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1