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

Model Number	VANC3
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that there was an online update applied to the vanc3 assay that was missing the reagent cap conditioning parameter file.By omitting the reagent cap conditioning step, it was found that it could, in very rare cases, cause inaccurately low results due to carry-over of concentrated reagent.The missing parameter file was determined to be the root cause of the event.The correct parameter file was released on (b)(6) 2022 and this resolved the issue.
Event or Problem Description
There was an allegation of questionably low vanc3 vancomycin results for 1 patient sample on a cobas pro c 503 analytical unit.The initial vanc3 result was 6.5.The repeat result was 9.5.The sample was re-centrifuged and the second repeat result was 9.5.The sample was repeated again on a fujirebio analyzer and the result was 11.0.The units of measurement were requested but not provided.It is unknown if the initial result was reported outside of the laboratory.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The sample was also received and tested at the investigational site and the vancomycin result was 8.8 ug/ml on (b)(6) 2023.The issue was resolved with the updated parameter file as stated in h10 of the initial report.

• 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: 16209913
• Report Number: 1823260-2023-00188
• Device Sequence Number: 19871692
• Product Code: LEH
• UDI-Device Identifier: 07613336121627
• UDI-Public: 07613336121627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 02/16/2023

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 Model Number: VANC3
• Device Catalogue Number: 08058849190
• Device Lot Number: 661222
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/16/2023
• 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