MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® CEFTAZIDIME TZ 256 WW S30

Catalog Number 412293

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 (b)(6) reported false susceptible ceftazidime (caz) results for a pseudomonas aeruginosa (atcc 27853) quality control strain, and a pseudomonas strain isolated from a patient in intensive care, in association with the etest® ceftazidime tz 256 ww s30 (lot 1005376560).The customer stated that the caz value for the qc strain was mic= 0.5mg/l (out of range low) instead of mic= 1-4 mg /l.A new qc strain was tested and the result was the same, mic=0.5mg/l.The patient strain was tested twice on the impacted lot and the result was caz mic = 4mg/l.The customer also performed the broth micro dilution method and a different i2a ast test on the impacted patient strain, and obtained correlated results of mic= 16 mg/l (resistant result).The customer stated that the false result had a clinical impact on the patient, but no additional information was provided.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in france had reported false susceptible ceftazidime (caz) results for a pseudomonas aeruginosa (b)(4) quality control strain, and a pseudomonas strain isolated from a patient in intensive care, in association with the etest® ceftazidime tz 256 ww s30 (lot: 1005376560).For the atcc strain, etest mic value obtained was 0.5 g/ml.The expected mic value range is 1-4 g/ml.The patient strain was susceptible with etest (mic=4 mg/l) and resistant with broth micro dilution (bmd) and the gradient strip from another supplier (16 mg/l).An internal biomérieux investigation was performed using the strains submitted by the customer.1.Retained samples analysis: the conformity of the impacted lot: 1005376560, and an internal reference lot: 1006213560, was used for the investigation and was confirmed with the atcc quality control strains tested for the release of this reference: (b)(4), staphylococcus aureus, (b)(4), escherichia coli, (b)(4), pseudomonas aeruginosa (internal strain and customer strain), (b)(4), haemophilus influenzae.2.Study on clinical strain received: the mic value obtained with the customer's clinical strain and the two etest lots (customer lot: 1005376560, and an internal reference lot: 1006213560) is equal to 8 g/ml.The customer's susceptible result was reproduced.This clinical strain has also been tested with the reference method used during the development of etest ceftazidime tz 256 strips: agar dilution.The mic value obtained was equal to 8 g/ml.The mic values obtained with etest strips and agar dilution are similar.Thus, the susceptible result obtained with etest strips is within conformance when compared with the reference method agar dilution.3.Complaints trend analysis: the trend analysis of the complaints does not show any problem on this reference.4.Conclusion: the results obtained with the atcc quality control strains tested during the investigation conformed with our specifications.The customer issue was not reproduced on the retained sample tested with the customer strain or internal strain of pseudomonas aeruginosa (b)(4).The results obtained with the patient strain and etest tz 256 strips are in conformance.The mic value of 8 ¿g/ml obtained with etest tz 256 strip is in agreement with the mic value of 8 ¿g/ml obtained with the reference method agar dilution.The same susceptible result was found with the two methodologies.Note : the mic value of 8 ¿g/ml found is equal to the value of eucast breakpoint that separate susceptible (s) and resistant (r) category (s result with mic 8) which can explain the discrepant category results obtained with bmd method and gradient strip from another supplier.A variation of just one double dilution of the mic value can induce a change of category.

• Brand Name: ETEST® CEFTAZIDIME TZ 256 WW S30
• Type of Device: ETEST® CEFTAZIDIME TZ 256 WW S30
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383; FR
• MDR Report Key: 7504475
• MDR Text Key: 108616790
• Report Number: 3002769706-2018-00065
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K971694
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2018
• Device Catalogue Number: 412293
• Device Lot Number: 1005376560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1