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

Catalog Number	08058849190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated the reagent pack used for the initial results was stored at room temperature for an extended period.The customer stated that they used a refrigerated reagent pack for the repeat results.The serial number of the customer's cobas pro c 503 analytical unit is 22m6-01.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable vanc3 vancomycin results from five patient samples tested on the cobas pro c 503 analytical unit.The initial results were reported outside of the laboratory.The results were questioned by the physician as higher results were expected, prompting the rerun of the patient samples.Sample 1.The initial result was 6 ug/ml.The repeat result was 10 ug/ml.Sample 2.The initial result was 6 ug/ml.The repeat result was 14 ug/ml.Sample 3.The initial result was 6 ug/ml.The repeat result was 12 ug/ml.Sample 4.The initial result was 6 ug/ml.The repeat result was 16 ug/ml.Sample 5.The initial result was 4 ug/ml.The repeat result was 16 ug/ml.The repeat results were deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the analyzer and determined that the event was caused by calibration and qc errors.The customer performed reruns and precision checks with successful results.The customer stated the reagent pack used for the initial results was stored at room temperature for an extended period.Product labeling states "storage and stability - shelf life at 2-8 °c: see expiration date on cobas c pack label; onboard in use and refrigerated on the analyzer: 12 weeks." the field service engineer (fse) inspected the analyzer and determined that the event was caused by calibration and qc errors.Good laboratory practice precludes running and/or reporting patient results when quality control has failed or not been performed.The investigation did not identify a product problem.

• Brand Name: ONLINE TDM VANCOMYCIN GEN.3
• Common Device Name: VANCOMYCIN ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18397226
• Report Number: 1823260-2023-04176
• Device Sequence Number: 14471267
• Product Code: LEH
• UDI-Device Identifier: 07613336121627
• UDI-Public: 07613336121627
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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): 01/25/2024

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: 08/31/2024
• Device Catalogue Number: 08058849190
• Device Lot Number: 70189301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/25/2024
• 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