MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® PIPERACILLIN-TAZOBACTAM

Catalog Number 412434

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 the (b)(6) contacted biomerieux on (b)(6) 2015 to report a low mic / false sensitivity on etest piperacillin/tazobactam.The customer obtained a susceptible result (etest mic = 2-4 mg/l) for a neqas sample when the expected result was resistant (mic = 64).Customer reported no delay in providing test results but cannot determine if patient results were affected.The customer did indicated the product was used for studies with isolates from selected patients.

Manufacturer Narrative

The investigation performed tests with the three quality control strains (e.Coli atcc 25922, p.Aeruginosa atcc 27853, k.Pneumoniae atcc 700603).E.Coli atcc 25922: range expected 1-4 g/ml, results obtained for agar dilution /broth microdilution/ lots 1004271120,1002995820, 1003977350, 1004397280 - 2 g/ml - conform.P.Aeruginosa atcc 27853: range expected 1-8 g/ml, results obtained for agar dilution /broth microdilution/ lot 1004271120,1002995820, 1003977350, 1004397280 - 2 or 4 g/ml - conform.K.Pneumoniae atcc 700603: range expected 8-32 g/ml, results obtained for agar dilution /broth microdilution/ lot 1004271120,1002995820, 1003977350, 1004397280 - 8 or 16 g/ml - conform, the investigation tested 18 customer isolates (including the (b)(6) strain) with etest ptc from four different lots (including two lots used by the customer) and compared the results with the reference mic on ad used for the development and bmd recommended by eucast and used by the customer.Only essential agreement errors (eae : mic > 1 dilution versus the reference method) and category (s, i , r) changes will be indicated, with focus on false susceptible results equating to very major error (vme).The investigation observed an underestimation of mic for each of the four lots compared to both broth microdilution (bmd) and agar dilution (ad).The investigation concluded that all four etest ptc lots performed outside of intended performance.The investigation identified the root cause as non-detection of a consequence due to a change of the manufacturing process on etest ptc256 (a deficiency in the biological representativeness of the strain collection used in the impact evaluation during the change control process).Product stop shipments (pss-2698 and pss-2701) and field safety corrective action (fsca-2709) were issued to prevent further shipment of product and to provide for field correction implementation.Corrective and preventive action (capa (b)(4)) was initiated to continue investigation of root cause and identify a means to prevent recurrence of the identified issue.A final report is expected in april 2016, including an in-depth study of approximately 200 clinical strains representative of the current intended use of the product (enterobacteria, pseudomonas, acinetobacter, haemophilus).For each group studied, resistance levels will be selected to cover the different levels of resistance representative of the current epidemiology.Etest®results (8 mg/l s) from customer lot 1004271120 and random lot 1004397280 are in essential agreement with ad but discrepant with the (b)(6) result and bmd.Etest® results (32 or 64 mg/l r) from customer lot 100295820 and random lot 1003977350 are in essential agreement error with ad, with major error but in agreement with bmd and (b)(6) results.The investigation supported that piperacillin/tazobactam mic results are dependent upon the reference method tested.The etest® ptc was developed to the agar dilution reference method and therefore may result in lower mic results when compared to broth micro dilution.The investigation was not able to reproduce the mic results between the 4 lots tested.A gap was observed with agar dilution and broth micro dilution methods in accordance with eucast breakpoints, and in a lesser extent according to clsi breakpoint.

• Brand Name: ETEST® PIPERACILLIN-TAZOBACTAM
• Type of Device: ETEST® PIPERACILLIN-TAZOBACTAM
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5271278
• MDR Text Key: 32818415
• Report Number: 3002769706-2015-00161
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K964203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2015
• Device Catalogue Number: 412434
• Device Lot Number: 1004271120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1