MAUDE Adverse Event Report: BIOMÉRIEUX SA ETEST® TICARCILLIN CLAVULANIC ACID

Catalog Number 522658

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in the united states reported a discrepant result (out-of-range-low) for eubacterium lentum atcc 43055, associated with etest® ticarcillin clavulanic acid tic/clav-con2 tlc 256 us f100.The customer reported obtaining an out of range lower mic.The expected values between 16 - 64 and the mic result obtain was 4 - 8.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There may be a potential for adverse event if the event were to reoccur while testing a patient isolate; therefore this event is being reported as a malfunction.Culture submittal was requested by biomérieux for internal investigation.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in the united states reported the occurrence of out-of-range-low (oorl) qc results (eggerthella lenta atcc® 43055¿) in association with the etest® tlc256 foam packaging (ref.522658) batches 1004598840 and 1004910630.On the supplement insert, the range for this qc strain is 16-64 ¿g/ml.The results of the customer were 4-8 ¿g/ml.The qc strain atcc® 43055¿ is not a strain that is tested for discharge control.A different anaerobic qc strain (bacteroides thetaiotaomicron atcc® 29741¿) is indicated in the u.S.Supplement insert; test results for this qc strain are within specification at the customer site.This last qc strain is tested for discharge control.Biomérieux investigation was conducted.The following qc strains claimed in the u.S.Package insert were tested with etest® tlc256 foam packaging (ref.522658) batches 1004598840 and 1004910630 (customer batches) and 1004439730 (reference batch): atcc® 27853¿ (pseudomonas aeruginosa), atcc® 25922¿ (escherichia coli), atcc® 29212¿ (enterococcus faecalis), atcc® 35218¿ (escherichia coli), atcc® 29741¿ (bacteroides thetaiotaomicron).The results for each qc strain were in specification for each of the three batches tested.The qc strain eggerthella lenta atcc® 43055¿ gave an oorl mic with each of the three batches tested.The expected range for this strain is 16-64 ¿g/ml while the results obtained were 6 or 8 ¿g/ml.Therefore, the non-conformity observed by the customer was reproduced.The batches were also tested with an incubation of 72 hours rather than 48 hours as performed by the customer.The package insert (ref.15203) indicates to incubate the strain during 24h, 48h or 72h: batch 1004598840 : mic = 8¿g/ml with 48 hours and 72 hours of incubation: oorl.Batch 1004910630 => mic = 8¿g/ml with 48 hours of incubation : oorl, and 12¿g/ml with 72 hours of incubation: oorl.Batch 1004439730 : mic = 6¿g/ml with 48 hours and 72 hours of incubation: oorl.Etest® tlc is widely used for susceptibility testing of gram-negative and gram-positive anaerobic bacteria.Since the quality control strain eggerthella lenta atcc® 43055¿ is recurrently out of range low, potential false susceptible results (s instead of r) might be obtained with this organism, as well as with the other gram-positive anaerobes which are clostridium, peptostreptococcus and propionibacterium.Of note, the anaerobic gram-negative bacteria are not impacted since the representative qc strain bacteroides thetaiotaomicron atcc® 29741¿ remains in range.A health hazard assessment (hha) was performed.The hha concluded that the overall risk to patients is minor to irrelevant.The investigation concluded the customer can continue to used etest® tlc256, except for gram-positive anaerobes in the event of gram-positive qc failure.

• Brand Name: ETEST® TICARCILLIN CLAVULANIC ACID
• Type of Device: ETEST® TICARCILLIN CLAVULANIC ACID
• Manufacturer (Section D): BIOMÉRIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer (Section G): BIOMÉRIEUX S.A.; 5, rue des aqueducs; craponne, fr 69290; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6441962
• MDR Text Key: 71325087
• Report Number: 3002769706-2017-00056
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951879
• 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,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2019
• Device Catalogue Number: 522658
• Device Lot Number: 1004598840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1