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

Model Number	VANCOMYCIN G3
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently ongoing.The follow up/corrective actions are yet to be determined.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 event.Erroneous low results were generated by two cobas 4000 c (311) stand alone systems.The event involved a total of 2 patients with erroneous results for vanc3 vancomycin.The ages of the patients were requested but were not provided.The weights of the patients were requested but were not provided the genders of the patients were requested but were not provided.The races of the patients were requested but were not provided.The ethnicities of the patients were requested but were not provided.
Additional Manufacturer Narrative
The investigation for the event did not identify a product problem.The cause of the event could not be determined.The field service representative replaced the gear pump assembly, the vacuum diaphragm, and probes.The probe washing positions and rinse levels were adjusted, all were ok.Rinse tubing was also replaced.Controls and patient sample comparison studies were performed.

• Brand Name: VANCOMYCIN
• Common Device Name: RADIOIMMUNOASSAY, VANCOMYCIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8281617
• Report Number: 1823260-2019-90004
• Device Sequence Number: 158658
• Product Code: LEH
• UDI-Device Identifier: 04015630934447
• UDI-Public: 4015630934447
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 01/28/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1