MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST TRIM/SULFA TEST STRIPS; ETEST® TRIM/SULFA TEST STRIPS

Catalog Number 524458

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of a potential false resistant sxt (trimethoprim/sulfamethoxazole) result in association with etest® trim/sulfa1/19 ts us f 100 test strips (ref.524458, lot 1007246260) when testing a patient staphylococcus hominis isolate.The customer tested the staphylococcus hominis isolate using the vitek® 2 ast-gp75 test kit and etest® trim/sulfa 1/19 ts us f 100 test strips.The following results were obtained: vitek® 2 ast-gp75 (initial): sxt terminated due to "insufficient growth in positive control well".Vitek® 2 ast-gp75 (repeat): mic=40, susceptible.Etest®: mic=>8, resistant.Biomérieux completed an internal investigation regarding the susceptible vitek® 2 results.The staphylococcus hominis strain was submitted and tested using the broth micro dilution test method, and obtained a susceptible result.This result indicated the vitek® 2 ast-gp75 test kit performed as intended.The customer stated the etest® result of resistant was reported to the treating physician; however, there is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of a potential false resistant sxt (trimethoprim/sulfamethoxazole) result in association with etest® trim/sulfa1/19 ts us f 100 test strips (ref.524458, lot 1007246260) when testing a patient staphylococcus hominis isolate.1.Retained samples analysis: a retained sample of the customer's lot number 1007246260 was tested in parallel with an internal reference lot (1007853860).The tests were performed using the quality control (qc) strains escherichia coli atcc 25922, haemophilus influenzae atcc 49247 and streptococcus pneumoniae atcc 49619 according to the quality control (qc) protocol used for the release of each lot number.The qc results obtained for the three strains tested are in accordance with the expected specifications for both lots etest® trim/sulfa 1/19 ts 32.There is no significant difference of results between the two lots tested for the three strains tested.2.Analysis of the strain provided: the customer's strain was submitted for investigational testing and the identification of the strain was confirmed to be staphylococcus hominis with the vitek® 2 gn id test kit.The customer's strain was tested with the agar dilution (ad) methodology as it was the reference method used for the etest® trim/sulfa 1/19 ts 32 development and with retained samples of etest® trim/sulfa 1/19 ts 32 strips from the customer's lot 1007246260 and a reference lot number 1006547590.Clsi 2020 (30th revision) clinical breakpoints were used to categorize the mic values.The following results were obtained : - ad ts: mic = 1 g/ml (susceptible) - etest® trim/sulfa 1/19 ts 32: mic = 2 g/ml (susceptible) on both lots.Etest® trim/sulfa 1/19 ts 32 mics for both lots are within essential agreement compared to the reference mic (ad) without any category error.3.Complaint trend analysis: a complaint trending analysis has been performed on the lot number 1007246260.No other complaints have been registered for this lot.Furthermore, since 2015, the complaint trending analysis does not show performance issue on the reference product etest® trim/sulfa 1/19 ts 32 reference 524458.4.Final conclusion: the results of quality control obtained during the investigation on the customer's lot (1007246260) complied with specifications.The resistant result obtained by the customer was not reproduced internally on the customer's strain.The etest® trim/sulfa 1/19 ts 32 mics are within essential agreement when compared to the reference method ad, without any category error.The trend analysis of the complaints does not show any deviation for the product etest® trim/sulfa 1/19 ts 32.As a conclusion, the performance of etest® trim/sulfa 1/19 ts 32 lot 1007246260 is within specifications and the investigation did not identify any product performance issue.See h10.

• Brand Name: ETEST TRIM/SULFA TEST STRIPS
• Type of Device: ETEST® TRIM/SULFA TEST STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10101988
• MDR Text Key: 241305492
• Report Number: 9615754-2020-00083
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026253271
• UDI-Public: 03573026253271
• Combination Product (y/n): N
• PMA/PMN Number: K983027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 524458
• Device Lot Number: 1007246260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1