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Catalog Number 522658
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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.
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.
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Manufacturer (Section D)
chemin de l orme
marcy l etoile, rhone 69280
Manufacturer (Section G)
5, rue des aqueducs
craponne, fr 69290
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6441962
MDR Text Key254114651
Report Number3002769706-2017-00056
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/19/2019
Device Catalogue Number522658
Device Lot Number1004598840
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial