MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM VANCOMYCIN GEN.3; VANCOMYCIN ASSAY

Model Number	VANC3
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that an electronic file did not contain the vanc3 application.The missing information might in very rare cases lead to inaccurately low vancomycin results.An updated electronic file was published to solve the issue.
Event or Problem Description
The initial reporter stated they received discrepant results for an unspecified number of samples tested with the vanc3 (online tdm vancomycin gen.3) assay on a cobas c 503 analytical unit, serial number (b)(4).No specific data on patient results being affected were provided.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The component code has been updated.

• Brand Name: ONLINE TDM VANCOMYCIN GEN.3
• Common Device Name: VANCOMYCIN ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16059991
• Report Number: 1823260-2022-04205
• Device Sequence Number: 2044623
• Product Code: LEH
• UDI-Device Identifier: 07613336121627
• UDI-Public: 07613336121627
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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 Expiration Date: 02/29/2024
• Device Model Number: VANC3
• Device Catalogue Number: 08058849190
• Device Lot Number: 661222
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown