MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA

Catalog Number 43841

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states reported the occurrence of false negative (no growth) for staphylococcus aureus cap survey organism in association with the chromid® (b)(6) agar.The cap survey was mrs5b-2016; specimen mrs-06 received on february 4th 2016.The expected result was positive for (b)(6).The customer indicated there were no colonies present on the chromid® (b)(6) plate after 24 hours of incubation.Testing via alternate method (pcr) obtained a positive result for (b)(6).The customer also indicated the plates are allowed to warm up to room temperature in a lighted environment.This practice is outside the instructions for use (ifu); the plates are to be protected from light at all times.The cap strain is no longer available for investigation.There is no indication or report from the customer to biomérieux that the occurrence led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey sample.Culture submittal is not available from the customer.Biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in the united states reported a false negative (no growth) for a staphylococcus aureus cap survey organism in association with the chromid® (b)(6) agar (udi (b)(4)).An investigation was performed.A review of quality records confirmed there were no discrepancies with the manufacturing of the lot number.Testing was performed on the biomérieux retained samples of the customer lot and a reference lot.Inoculation of the retained samples followed the qc method with qc strains.In parallel, a batch of gts media was used for control.The following results were obtained : good growth of pink colonies for the (b)(6) strain tested (s.Aureus atcc 43300) after 24 hours of incubation on both customer and reference lots of chromid (b)(6).Total inhibition for the (b)(6) strains tested (s.Aureus 0504605, s.Aureus 0506614, s.Aureus atcc 29213) after 24 hours of incubation and 48 hours for the atcc strain.Total inhibition for e.Coli atcc 8739 and c.Albicans atcc 10231 after 48 hour of incubation.Partial inhibition for e.Faecalis atcc 29212 after 48hours of incubation.All results conformed with specifications for the media and were equivalent between both lots tested.The instructions for use, challenge testing section states, "a challenge set composed of 80 meca (b)(6) strains and 5 mecc (b)(6) strains was inoculated on the chromid (b)(6) medium with an inoculum equivalent to 103 cfu/ml.After 24 hours of incubation, the following results were observed.58/80 (72.5%) of meca (b)(6) strains and 4/5 (80%) of mecc (b)(6) strains were detected on the chromid (b)(6) medium." thus we assume that certain strains of (b)(6) can not be detected.The investigation did not reproduce the issue observed by the customer on the retained samples.Without return of customer isolate, it is not possible to continue the investigation.

• Brand Name: CHROMID® MRSA
• Type of Device: CHROMID® MRSA
• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6096960
• MDR Text Key: 59875226
• Report Number: 3002769706-2016-00474
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2016
• Device Catalogue Number: 43841
• Device Lot Number: 1005073250
• Other Device ID Number: 03573026313111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• 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