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

Catalog Number	06779336190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable vanc2 vancomycin result for 1 patient sample on a cobas 8000 cobas c 502 module.The vancomycin result was 12.2 mg/l.The doctor questioned the high result as there was no clinical documentation of the patient receiving vancomycin and expected the result to be 0.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation determined that there was no vanc3 assay cross-reactivity with daptomycin.The investigation determined the event was consistent with a patient sample containing vancomycin.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The medical coding of this case has been updated.

• 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: 19645019
• Report Number: 1823260-2024-01900
• Device Sequence Number: 7479553
• Product Code: LEH
• UDI-Device Identifier: 04015630934416
• UDI-Public: 04015630934416
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 09/24/2024

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: 06779336190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 09/23/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BISOPROLOL; CANDSARTAN; DAPTOMYCIN; DEKRISTOL; GABAPENTIN; HEPARIN; HYDROMORPHON; JONOSTERIL; MACROGOL; ONDANSETRON; PALADON; TIZANIDIN; TORASEMID
• Patient Sex: Unknown