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

Model Number	6E44-21
Medical Device Problem Code	Cross Reactivity (1137)
Health Effect - Clinical Code	Toxemia (2207)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a discrepant vancomycin patient result of <1.1 on a patient who was receiving vancomycin.It was retested on other architect in the lab and the result was repeatable, sample repeated in 1:4 dilution and read 14.4.Sample was aliquoted and sent to a reference lab and was tested by the siemens vanco assay and got a result of 32.0 ng/ml.The problem started on (b)(6) 2017, customer had 4 random draws and 2 draws were done after medication was given between the dates (b)(6).The same patient draw from (b)(6) 2017 the patient result was 16.4.No issues with other assays qc all in range and the retest of the proficiency sample produced repeatable results from the original testing.Customer concluded that the sample is the cause of the problem.

• 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: 7124396
• Report Number: 3010939897-2017-00003
• Device Sequence Number: 1423290
• Product Code: LEH
• UDI-Device Identifier: 00380740009847
• UDI-Public: 00380740009847
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K050419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: Other
• Device Expiration Date: 09/15/2018
• Device Model Number: 6E44-21
• Device Catalogue Number: 6E44-21
• Device Lot Number: 39468FD01
• 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: 11/21/2017
• 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
• Patient Age: 25 YR