MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PURE SAMPLE SUPPLY UNIT

Catalog Number	09793178001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mg2 reagent lot number was 75024001 with an expiration date of 30-jun-2025.The field service engineer (fse) replaced the reagent probe and performed reagent probe adjustments.The rinse station and main water pressure were adjusted.The fluidic levels were checked and adjusted.Calibration was last performed on 10-apr-2024 and was acceptable.Qc was acceptable.An "abnormal aspiration" alarm was observed on the alarm trace data.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter questioned the results for roche diagnostics magnesium reagent (mg2), creatine, and alt for multiple patient samples tested on a cobas pure instrument.The customer provided examples of discrepant results for 2 patient samples tested for mg2.Patient 1 initial result was 3.2 mg/dl.The repeat result was 2.3 mg/dl.Patient 2 initial result was 2.9 mg/dl.The repeat result was 2.0 mg/dl.The samples were repeated as the initial results did not correspond to the patient¿s clinical history.The repeat results were believed to be correct.The questionable results were not reported outside of the laboratory.

• Brand Name: COBAS PURE SAMPLE SUPPLY UNIT
• Common Device Name: SAMPLE SUPPLY UNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19313173
• Report Number: 1823260-2024-01444
• Device Sequence Number: 19608597
• Product Code: JQP
• UDI-Device Identifier: 07613336220146
• UDI-Public: 07613336220146
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• 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
• Report Date (Section B): 05/14/2024

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 Catalogue Number: 09793178001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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