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

Catalog Number	06779336190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with vanc3 (vancomycin) on a cobas 4000 c311 stand alone system.The sample resulted in a vancomycin value of 8.4 ug/ml when tested on the c311 system.The doctor questioned the value since the patient had been receiving increasing doses of vancomycin, but the results were always low.Another tube collected at the same time was sent to another facility where it was tested for vancomycin using an unknown method on (b)(6) 2023.The vancomycin result for this tube was > 50.0 ug/ml.
Additional Manufacturer Narrative
The serial number of the c311 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The calibration performed on 31-aug-2023 was successful.The customer only ran one level of control around the day of the event.The control recovery was within range.Since calibration and controls are within range, a reagent or instrument issue can be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.A sample from the patient was requested for investigation, but could not be provided.The issue is consistent with an interfering factor in the patient's sample that interferes with a component of the assay.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17801165
• Report Number: 1823260-2023-03068
• Device Sequence Number: 6727576
• Product Code: LEH
• UDI-Device Identifier: 04015630934416
• UDI-Public: 04015630934416
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• 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): 10/23/2023

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: 09/30/2023
• Device Catalogue Number: 06779336190
• Device Lot Number: 63880901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 9 YR
• Patient Sex: Male