MAUDE Adverse Event Report: BIOMERIEUX SA ETEST CEFTRIAXONE TX 32 WW S30; ETEST® CEFTRIAXONE TX 32 WW S30

Catalog Number 412303

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 in (b)(6) notified biomérieux of false resistant ceftriaxone results when testing a streptococcus anginosus strain with etest® ceftriaxone tx 32 ww s30 (ref 412303, lot 1007439280, expiry date 30-jun-2020).Etest test 1 (lot 1007439280): ceftriaxone mic = 1 mg/l (resistant); etest test 2 (lot 1007439280): ceftriaxone mic = 1 mg/l (resistant); etest test 3 (lot 1007702120 ): ceftriaxone mic = 0.5 mg/l (susceptible).The resistant results were initially reported to the physician.The physician received the ceftriaxone resistant results and changed the patient's treatment from ceftriaxone to tavanic.After the physician received the final test result of ceftriaxone susceptible, treatment with ceftriaxone was resumed.There is no indication or report from the customer that the false resistant result and antibiotic treatment changes led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 412303 is not registered in the united states.The u.S.Similar device is product reference 412302.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding false resistant ceftriaxone results when testing a streptococcus anginosus strain with etest® ceftriaxone tx 32 ww s30 (ref 412303, lot 1007439280, expiry date 30-jun-2020).Repeat analysis with the same lot obtained the same resistant result.A second lot was used for additional repeat analysis and a susceptible result was obtained.Etest test 1 (lot 1007439280): ceftriaxone mic = 1 mg/l (resistant).Etest test 2 (lot 1007439280): ceftriaxone mic = 1 mg/l (resistant).Etest test 3 (lot 1007702120): ceftriaxone mic = 0.5 mg/l (susceptible).A biomérieux internal investigation has been completed with the following results: the impacted lot of the customer was not tested because it was expired.Two different lots (internal reference lot 1( lot: 1007702120) and internal reference lot 2 (lot: 1007880020)) were tested.Multiple atcc strains were tested on three strips of each lot.All atcc strains gave conform results on both lots tested.The identification of the provided strain was confirmed as streptococcus anginonus using the vitek® ms.It should be noted that the casfm eucast_v1.1 april 2020 ceftriaxone breakpoints for viridans group streptococcus are s <= 0.5 - r > 0.5.-broth microdilution was used as a reference method to determine the expected mics for ceftriaxone (cro mic = 0.5 mg/l, susceptible).It was determined that this strain is considered as a borderline strain because the mic is on the breakpoint so it can be ¿s¿ or ¿r¿ within 1 doubling dilution.Three strips were tested on each lot on mhf (ref 43091 commercial) and on mh-bl faf (ref 410325 in-house manufacture) with the following results: mhf (ref 43091).Etest tx mic = 0.5 g/ml, susceptible on both lots.Mh-bl faf (ref 410325): etest tx mic = 0.75 g/ml, rounded-up to 1 g/ml resistant on the reference lot 1.Etest tx mic = 0.5 g/ml, susceptible on the reference lot 2.In conclusion, the etest tx32 resistant results obtained by the customer were reproduced partially in-house.The etest results (0.5 g/ml, susceptible and 1 ¿g/ml, resistant) were within essential agreement compared to the reference mic (broth microdilution, bmd mic = 0.5 g/ml s) without any category error, except for the mh-bl faf medium with reference lot 1.In that case the mic was equal to 1 g/ml, resistant and lead to a major category error.The strain was determined to be a borderline strain because the mic is on the breakpoint so it can be ¿s¿ or ¿r¿ within 1 doubling dilution.The etest tx32 is performing as expected.A complaint search showed that there have been no other complaints registered for this lot number and a complaint trend analysis going back to 2015 does not show any performance issue for product reference etest® ceftriaxone (tx 32) (0,002 ¿ 32 g/ml) s30, reference 412303.See section h10.

• Brand Name: ETEST CEFTRIAXONE TX 32 WW S30
• Type of Device: ETEST® CEFTRIAXONE TX 32 WW S30
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme ; FR
• MDR Report Key: 10220974
• MDR Text Key: 241355057
• Report Number: 9615754-2020-00109
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K981139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 412303
• Device Lot Number: 1007439280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1