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

Catalog Number	08445605190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was a complaint of discrepant vancomycin immunoassay results for one patient between two cobas 6000 c501 module serial numbers (b)(4) and a bm nanopia (sekisui) using online tdm vancomycin gen.3.On (b)(6) 2021, the initial results gave an unknown numeric value and had an alarm indicating unusual reaction kinetics.The sample was centrifuged and the same result was obtained; the numerical result was requested but not provided.The sample was diluted and resulted in the alarm indicating unusual reaction kinetics.The results were the same for both cobas 6000 c501 modules.On (b)(6) 2021, the sample was repeated on a cobas and produced a result of 4.8 ug/ml.On (b)(6) 2021, the customer took a new blood sample from the patient and ran the new sample.The result was 4.8 ug/ml on the cobas c501.The result was around 19-20 ug/ml on the bm nanopia.
Additional Manufacturer Narrative
The investigation determined the alarm accompanying the initial result correctly alerted the user to an issue with the sample.For the unusual reaction kinetics alarm, product labeling states: "there is a high possibility that the sample contains an interfering substance which accelerates the reaction kinetics.For such samples it is not possible to report a reliable analyte concentration with this assay.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other finding." the investigation did not identify a product problem.

• Brand Name: ONLINE TDM VANCOMYCIN GEN.3
• Common Device Name: VANCOMYCIN IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12475904
• Report Number: 1823260-2021-02693
• Device Sequence Number: 3613179
• Product Code: LEH
• UDI-Device Identifier: 07613336157800
• UDI-Public: 07613336157800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 12/31/2021
• Device Catalogue Number: 08445605190
• Device Lot Number: 450529
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1