MAUDE Adverse Event Report: ROCHE DIAGNOSTICS VANC3; RADIOIMMUNOASSAY, VANCOMYCIN

Catalog Number	06779336190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient tested with vancomycin (vaan3) assay on a cobas 6000 c501 module serial number (b)(4).On (b)(6) 2023 the customer ran the sample and got the following results: initial result: 0.0 mg/dl with a data flag.Re-test result: 0.0 mg/dl with a data flag.The questionable results were reported outside the laboratory.The physician doubted the results and asked for the sample to be repeated.Re-test result: 12.3 mg/dl (2nd re-test) re-test result: 13.1 mg/dl (3rd re-test).
Additional Manufacturer Narrative
The investigation determined that the cause of the event was consistent with a pre-analytical issue.

• Brand Name: VANC3
• Common Device Name: RADIOIMMUNOASSAY, VANCOMYCIN
• 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: 16762860
• Report Number: 1823260-2023-01303
• Device Sequence Number: 16910184
• Product Code: LEH
• UDI-Device Identifier: 04015630934416
• UDI-Public: 04015630934416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060586
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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 Catalogue Number: 06779336190
• Device Lot Number: 661212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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