MAUDE Adverse Event Report: MICROGENICS CORPORATION ABBOTT VANCOMYCIN ASSAY; VANCOMYCIN TEST SYSTEM, PRODUCT CODE: LEH

Model Number	6E44-21
Medical Device Problem Code	Cross Reactivity (1137)
Health Effect - Clinical Code	Toxemia (2207)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6).Customer is not willing to give patient information or if treatment was given.Both tubes were plasma spun at 10 min at 5000 rpm.On (b)(6) 2017 t19:16:43z : chatfam : : new lot of cal and rtg being sent in for trouble shooting ncchatfam (b)(6) 2017 1420.

• Brand Name: ABBOTT VANCOMYCIN ASSAY
• Common Device Name: VANCOMYCIN TEST SYSTEM, PRODUCT CODE: LEH
• Manufacturer (Section D): MICROGENICS CORPORATION; 46500 kato road; fremont CA 94538
• MDR Report Key: 7124389
• Report Number: 3010939897-2017-00004
• Device Sequence Number: 2144462
• Product Code: LEH
• UDI-Device Identifier: 00380740009847
• UDI-Public: 00380740009847
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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: Medical Technologist
• Device Model Number: 6E44-21
• Device Catalogue Number: 6E44-21
• Device Lot Number: 713346FD01
• 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: 12/01/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other