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

Catalog Number	08445605190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer checked probe alignments, probe washes, pump pressures, and rinse levels to ensure proper operation.The customer ran calibration and controls; all values were within the customer's specifications.
Event or Problem Description
The initial reporter stated they have been having issues with vanc3 vancomycin recovery on the cobas pro c 503 analytical unit.Control recovery will go higher and then they have to recalibrate.After recalibrating, the customer will pull patient samples that were previously tested and repeat these.The reporter provided data for one patient sample that had discrepant vancomycin results.The sample initially resulted in a vancomycin value of 48.8 ug/ml and this value was reported outside of the laboratory.The sample was pulled and repeated after controls went high and the assay was recalibrated.The repeat result was 38 ug/ml on (b)(6) 2022.The repeat value was deemed correct and a corrected report was issued.The serial number of the c 503 analyzer is 2190-03.
Additional Manufacturer Narrative
Investigations have determined that calibration frequency specifications were not met for the vancomycin assay.There was a downward drift in measurement signals for the reagent pack in use.This leads to a higher recovery in quality controls and patient samples for the reagent pack in use.Notifications have been sent to customers alerting them of this issue.It is recommended to customers to carefully monitor control intervals and recovery.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14240668
• Report Number: 1823260-2022-01214
• Device Sequence Number: 12022816
• 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): Unknown
• 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): 06/09/2022

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 Catalogue Number: 08445605190
• Device Lot Number: ASKU
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/09/2022
• 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