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

Catalog Number	08058849190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Calibration was last performed on 02-jul-2024.The customer stated that their qc was acceptable.The alarm trace showed an abnormal sample probe movement, sample short, and abnormal aspiration alarms.The field service engineer (fse) found that the fluidics pathway was compromised.The fse replaced solenoid valves, diaphragms, rinse tubing, the sampling mechanism, and sample and reagent probes.The fse decontaminated the analyzer, confirmed rinse levels and probe adjustments, adjusted the cell blank level, and performed precision testing and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.
Event or Problem Description
There was an allegation of questionable vanc3 vancomycin results for 3 patient serum samples on a cobas 8000 cobas c 502 module.The doctor questioned the initial low results which prompted the customer to repeat the samples.For sample 1, the initial vanc3 result was <4 ug/ml with flag.The sample was repeated on another c502 analyzer and the result was 19.3 ug/ml.For sample 2, the initial vanc3 result was <4 ug/ml with flag.The sample was repeated on another c502 analyzer and the result was 8.1 ug/ml.For sample 3, the initial vanc3 result was <4 ug/ml with flag.The sample was repeated on another c502 analyzer and the result was 8.1 ug/ml.The repeat results were deemed correct.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19999472
• Report Number: 1823260-2024-02399
• Device Sequence Number: 7414200
• Product Code: LEH
• UDI-Device Identifier: 07613336121627
• UDI-Public: 07613336121627
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: 746091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 08/19/2024
• 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: 49 YR
• Patient Sex: Male