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

Catalog Number	08445605190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable vanc2 vancomycin results for 2 patient samples on a cobas pro c 503 analytical unit.The initial results were reported outside of the laboratory.The customer was prompted to repeat the samples after qc was performed and was outside of the acceptable range.For patient 1, the initial vanc2 result was 11.9 ug/ml.The sample was repeated in duplicate on another analyzer and the results were 9.2 ug/ml and 9.5 ug/ml.For patient 2, the initial vanc2 result was 10.6 ug/ml.The sample was repeated in duplicate on another analyzer and the results were 8.3 ug/ml and 8.0 ug/ml.The repeat results were deemed correct.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
Qc was within range prior to the event.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.The field service engineer (fse) replaced syringe seals and the heat cut filter, flushed the sample and reagent probes, and checked the rinse levels.The investigation did not identify a product problem.The root cause of the event could not be determined.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 16016297
• Report Number: 1823260-2022-04110
• Device Sequence Number: 6738350
• Product Code: LEH
• UDI-Device Identifier: 07613336157800
• UDI-Public: 07613336157800
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 09/30/2023
• Device Catalogue Number: 08445605190
• Device Lot Number: 64125401
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/06/2023
• 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