MAUDE Adverse Event Report: MICROGENICS CORPORATION MULTIGENT 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 Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Ivd test for vancomycin revealed unusually low result.

• Brand Name: MULTIGENT ABBOTT VANCOMYCIN ASSAY
• Common Device Name: VANCOMYCIN TEST SYSTEM
• Manufacturer (Section D): MICROGENICS CORPORATION; 46500 kato road; fremont CA 94538
• MDR Report Key: 8017680
• Report Number: 3010939897-2018-00003
• Device Sequence Number: 13824024
• Product Code: LEH
• UDI-Device Identifier: 00380740101220
• UDI-Public: (01)00380740101220(17)181130(10)69059FD01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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 Model Number: 6E44-21
• Device Catalogue Number: 6E44-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other