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

Model Number	VANCOMYCIN G3
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 found the issue is related to flagged test results indicating unusual kinetics.Product labeling states: "a test result flagged with ">kin" indicates unusual reaction kinetics.There is a high possibility that the sample contains an interfering substance that accelerates the reaction kinetics.For such samples it is not possible to report a reliable analyte concentration with this assay.".
Event or Problem Description
The initial reporter received questionable vanc3 vancomycin results for one patient on three different samples with the cobas 6000 c501 module serial number 19a4-14.Sample 1: on 21-aug-2021, the initial result was 0 ug/ml with a flag indicating unusual kinetics.The sample was diluted with a result of <4 ug/ml.On 27-aug-2021, the sample was tested on a fujirebio g1200 with a result of 11.00 ug/ml.Sample 2: on 24-aug-2021, the initial result was 0 ug/ml with a flag indicating unusual kinetics.The sample was diluted with a result of <4 ug/ml.On 27-aug-2021, the sample was tested on a fujirebio g1200 with a result of 14.40 ug/ml.Sample 3: on 27-aug-2021, the initial result was 0 ug/ml with a flag indicating unusual kinetics.The sample was performed on 1:10, 1:20, 1:40, and 1:200 dilution with results of <4 ug/ml.On 27-aug-2021, the sample was tested on a fujirebio g1200 with a result of 30.6 ug/ml.On 08-sep-2021, all three samples were sent to an investigation lab for testing with results of 0 ug/ml with a flag indicating unusual kinetics.The questionable results were reported outside of the laboratory.The fujirebio g1200 results on 21-aug-2021 and 24-aug-2021 were deemed correct and corrected reports were sent.

• Brand Name: VANCOMYCIN
• Common Device Name: RADIOIMMUNOASSAY, VANCOMYCIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12488636
• Report Number: 1823260-2021-02721
• Device Sequence Number: 14290253
• Product Code: LEH
• UDI-Device Identifier: 04015630934447
• UDI-Public: 04015630934447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060586
• 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
• Report Date (Section B): 09/17/2021

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 Model Number: VANCOMYCIN G3
• Device Catalogue Number: 06779344190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR