MAUDE Adverse Event Report: MICROGENICS CORPORATION ABBOTT VANCOMYCIN ASSAY; VANCOMYCIN TEST SYSTEM

Model Number	6E44-21
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The customer began using a new lot of vancomycin reagent lot 71368fd01.Prior to accepting the use of the new reagent lot, the customer calibrated and ran qc along with some archived patent samples to check the performance.Qc results were all in range with both lots.The customer had a couple of leftover patient samples with original values (on previous reagent lot 71346fd01) that were in the 31-34 ug/ml range.The customer decided to rerun leftover customer samples in parallel on the new and the old reagent lots.Customer observed low result of <1.1ug/ml only on the new reagent lot.Customer diluted the sample and tested it again on the new reagent lot and obtained a result of 29 ug/ml customer concluded that the discrepancy is within the patient sample.

• Brand Name: ABBOTT VANCOMYCIN ASSAY
• Common Device Name: VANCOMYCIN TEST SYSTEM
• Manufacturer (Section D): MICROGENICS CORPORATION; 46500 kato road; fremont CA 94538
• MDR Report Key: 7295374
• Report Number: 3010939897-2018-00001
• Device Sequence Number: 1801540
• Product Code: LEH
• UDI-Device Identifier: 00380740009847
• UDI-Public: 00380740009847
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date (Section B): 02/02/2017

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 Expiration Date: 02/07/2019
• Device Model Number: 6E44-21
• Device Catalogue Number: 6E44-21
• Device Lot Number: 71368FD01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 02/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1