MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® CEFTAROLINE

Model Number 537540

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of an "odd result" associated with etest® ceftaroline cpt 32 us b30 (reference 537540).The issue came up during testing of a quality control sample.Another test from a different lot was opened and the test run appropriately.There is no patient involved this event occurred during a quality control test.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

This investigation was initiated due to an odd result with etest ceftaroline cpt 32 us b30 ref 537540 and staphylococcus aureus atcc 29213.Given that the customer could not provide biomerieux with the lot numbers he used, the batches sent to this customer were searched internally.In conclusion, no batches of this reference 537540 have been sent to this customer since january 2014.The shelf life of this reference being two years, it's impossible for the customer to have used a non-expired lot.Because of this, no further investigation will be performed.

• Brand Name: ETEST® CEFTAROLINE
• Type of Device: ETEST® CEFTAROLINE
• Manufacturer (Section D): BIOMERIEUX SA; te, 3 route de port michaud; 38390 la balme-les-grottes; FR
• Manufacturer (Section G): BIOMERIEUX SA; te, 3 route de port michaud; 38390 la balme-les-grottes; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6921539
• MDR Text Key: 89937159
• Report Number: 3002769706-2017-00290
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026261658
• UDI-Public: 03573026261658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151873
• 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
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 537540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• 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