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

Catalog Number	08445605190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for online tdm vancomycin gen.3 (vanc3) on a cobas pro c 503 analytical unit.The initial result was 6.64 ug/ml.This result was reported outside of the laboratory.An additional result of 6.68 ug/ml was also provided for this sample.On (b)(6) 2022 a new sample was obtained and the results were 14.7 ug/ml and 14.8 ug/ml.These results were reported outside of the laboratory.Due to these results, the initial result was questioned.On (b)(6) 2022 the original sample was repeated and the result was 9.63 ug/ml.This result was not reported outside of the laboratory.The c503 unit serial number was (b)(4).
Additional Manufacturer Narrative
The customer submitted both samples for investigation where the result from the original sample ((b)(6) 2022) was 9.9 ug/ml and the result from the 2nd sample ((b)(6) 2022) was 14.1 ug/ml.Calibration and qc were acceptable.The reaction monitors provided were for the repeat result from the original sample and the 2nd sample.The reaction monitor was not provided for the original result in question.Since calibration and qc were acceptable, both a general reagent and instrument issue can be excluded.The investigation determined the event was consistent with a sample pipetting issue which may be related to a pre-analytical issue.
Additional Manufacturer Narrative
The component code was updated.

• Brand Name: ONLINE TDM VANCOMYCIN GEN.3
• Common Device Name: VANCOMYCIN IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15402131
• Report Number: 1823260-2022-02786
• Device Sequence Number: 12026247
• 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
• 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
• Report Date (Section B): 10/19/2022

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: 06/30/2023
• Device Catalogue Number: 08445605190
• Device Lot Number: 61931701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown