MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID VRE ID AGAR; CHROMID¿ VRE ID AGAR

Model Number 43004

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with chromid¿ vre id agar (reference (b)(4)).The customer reported that the media had a bad selectivity for susceptible vancomycin enterococci.The customer provided five (5) examples that resulted in false positive results.The samples were collected from the rectal region for vre screening.The plates were streaked directly from the collected rectal swab and incubated for 24 - 48 hours.Results were as follows: sample a: growth on vre agar after 48 h incubation, vitek 2 susceptible (mic 1).No etest result.Sample b: growth on vre agar after 48 h incubation, vitek 2 susceptible (mic 1).Va-etest = 1,0 ¿g/ml (s).Sample c: growth on vre agar after 24 h incubation, vitek 2 susceptible (mic 2).Va-etest = 2,0 ¿g/ml (s).Sample d: growth on vre agar after 24 h incubation, vitek 2 susceptible (mic 2).Va-etest = 4,0 ¿g/ml (s).Sample e: growth on vre agar after 48 h incubation, vitek 2 susceptible (mic 1).No etest result.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of discrepant results associated with chromid vre id agar (lot 1005580260).The customer reported that five (5) rectal swabs from five (5) different patients showed growth of blue/purple colonies after 24 or 48 hours of incubation.Vitek 2® and etest results were sensitive.The customer provided the patient strains for the investigation.An investigation was performed.A review of quality records confirmed chromid vre id agar lot 1005580260 was manufactured in accordance with specifications and met the criteria for quality control and final release.There were no non-conformities or deviations recorded on this lot number.Analysis and bacteriologic testing was performed on retained chromid vre id agar sample plates of the impacted lot numbers, 1005616590, 1005659000, along with a reference lot number 1005635740.The impacted lot number 1005580260 was not tested because it had expired at the time of the investigation.Sample plates of various different manufacturing times were tested using the following quality controls; e.Faecalis atcc 51299 bmr, e.Faecium atcc 700221 bmr, e.Faecium 3-299 scv bmr, e.Faecalis atcc 29212, e.Coli atcc 25922, s.Aureus atcc 25923, c.Tropicis atcc 9968 and k.Oxytoca 9009075 bmr, p.Pentasaceus 07 11 603, e.Gallinarum 05 02 053.A strain of staphylococcus epidermidis atcc 12228 was also tested as one customer had reported growth of staphylococcus epidermidis at 24hrs of incubation.All results obtained conformed with specifications, and were equivalent between the lots in question and the reference lot.There was good inhibition of growth of enterococcus with no acquired resistance to vancomycin.Enterococcus that express natural vancomycin resistance, yeast and other gram positive strains tested, including staphylococcus epidermidis atcc 12228, were observed.The customer's returned five patient strains for which false positive results were obtained, were identified on the vitek® ms as enterococcus faecalis.The five strains were tested on various different plate manufacturing times for lot 1005659000, as it was within expiry, and on a reference lot number 1005678490, at expiration date.After 48 hours of incubation, an expected total inhibition of growth of these five strains was observed.The results obtained were equivalent between the impacted lot and the reference lot.The investigation did not reproduce the issue observed by the customer.In conclusion, the impacted lot numbers conformed with quality control specifications.The bacteriological performance of the retained sample plates indicated that the results conformed with specifications.The issue observed by the customer was not reproduced by the investigation, the product, chromid vre id agar (lot 1005580260) performed as intended.

• Brand Name: CHROMID VRE ID AGAR
• Type of Device: CHROMID¿ VRE ID AGAR
• Manufacturer (Section D): BIOMERIEUX SA; 5, rue des aqueducs; craponne, fr 69290; FR
• Manufacturer (Section G): BIOMERIEUX SA; 5, rue des aqueducs; craponne, fr 69290; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6744474
• MDR Text Key: 81244607
• Report Number: 3002769706-2017-00208
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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: 06/06/2017
• Device Model Number: 43004
• Device Lot Number: 1005580260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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