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

Model Number	VANCOMYCIN G3
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.Erroneous high results were generated by a cobas 8000 c 502 module.The event involved 1 patient with vanc3 vancomycin.The provided patient's age was (b)(6) years.The patient was a female.
Additional Manufacturer Narrative
Summary of investigation results: since calibration and qc were acceptable, both a general reagent and instrument issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.Summary of follow up actions taken: the sample was requested for investigation but could not be provided.

• Brand Name: VANCOMYCIN
• Common Device Name: RADIOIMMUNOASSAY, VANCOMYCIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8556134
• Report Number: 1823260-2019-90162
• Device Sequence Number: 2358884
• Product Code: LEH
• UDI-Device Identifier: 04015630934447
• UDI-Public: 04015630934447
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: No Information
• Device Model Number: VANCOMYCIN G3
• Device Lot Number: 29046601
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1