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

Catalog Number	08058849190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable vanc2 vancomycin results for 5 samples from the same patient on a cobas pro c 503 analytical unit.For sample 1, the initial result was 14.1 mg/l.The sample was repeated in another laboratory and the result was 63.7 mg/l.For sample 2, the initial result was 7.9 mg/l.The sample was repeated in another laboratory and the result was 38.4 mg/l.For sample 3, the initial result was < 4 mg/l.The sample was repeated in another laboratory and the result was 7.5 mg/l.For sample 4, the initial result was < 4 mg/l.The sample was repeated in another laboratory and the result was 7.5 mg/l.For sample 5, the initial result was 11.7 mg/l.The sample was repeated in another laboratory and the result was 47.1 mg/l.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Calibration was last performed on (b)(6) 2023.The qc recovery data provided was acceptable.The customer confirmed that the patient does not have a gammopathy.The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Based on the calibration and qc data, a general reagent issue could be excluded.Five patient samples were received for investigation.The customer's results were able to be confirmed.An interfering factor that accelerates the aggregation of microparticle was confirmed in the patient's samples and as the root cause of the event.Per product labeling, "in very rare cases (less than 1 reported case per 1000000 tests) certain immunoglobulins can unspecifically interfere with the agglutination reaction leading to unreliable results.".
Additional Manufacturer Narrative
H6 investigation findings code was updated.

• 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: 17869812
• Report Number: 1823260-2023-03180
• Device Sequence Number: 20590149
• Product Code: LEH
• UDI-Device Identifier: 07613336121627
• UDI-Public: 07613336121627
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 08058849190
• Device Lot Number: 70189301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 08/01/2024; 11/28/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 08/22/2024; 12/12/2024
• 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: AMANTADINE; DAPAGLIFLOZINE; FUROSEMIDE; ISOSORBIDEDINITRAAT; LEVODOPA/CARBIDOPA; LOSARTAN; METAMIZOL; METFORMINE; METOPROLOL; NADROPARINE; NOVOMIX; ONDANSETRON; OXYCODON; PIPERACILLINE/TAZOBACTAM; SIMVASTATINE; ULTIBRO BREEZHALER
• Patient Sex: Unknown