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

Catalog Number	08058849190
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable online tdm vancomycin gen.3 results from the cobas c 503 analytical unit for one patient.Sample 1's initial result was 23 ug/ml.The first repeat result was 1.52 ug/ml, accompanied by a data flag.The second repeat result was 13.3 ug/ml.This sample was sent to another laboratory, and the result on an unspecified analyzer was 50 ug/ml.The sample was repeated after a 1:2 dilution, and the result was 44 ug/ml.Sample 2's initial result was 7 ug/ml.The first repeat result was 0.0839 ug/ml, accompanied by a data flag.The second repeat result was 19.9 ug/ml.Sample 3's initial result was 4 ug/ml.Sample 4's initial result was 2.11 ug/ml, accompanied by a data flag.The repeat result was 17.2 ug/ml.Two of the samples were ran on the cobas c 503 analytical unit.The other two samples were ran on a different module that was not specified.
Additional Manufacturer Narrative
The calibration results were acceptable.A field service engineer (fse) evaluated the instrument and was unable to determine a root cause for the issue.The fse indicated that a sample issue could be present.The customer diluted the patient samples using the prescribed diluent and dilution factor; valid assay results were obtained.A further investigation was not possible as the patient sample is not available for investigation.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24324670
• Report Number: 1823260-2026-00503
• Device Sequence Number: 18654333
• Product Code: LEH
• UDI-Device Identifier: 07613336121627
• UDI-Public: 07613336121627
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 08058849190
• Device Lot Number: 879771
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "ND-5S"; ROCEPHIN
• Patient Sex: Unknown