MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® CEFTAROLINE

Model Number	537540
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ETEST® CEFTAROLINE
• Manufacturer (Section D): BIOMERIEUX SA; te, 3 route de port michaud; 38390 la balme-les-grottes; FR
• MDR Report Key: 6921539
• Report Number: 3002769706-2017-00290
• Device Sequence Number: 851675
• Product Code: JWY
• UDI-Device Identifier: 03573026261658
• UDI-Public: 03573026261658
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 537540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1