MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C502
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable total protein (tpuc3) assay results from one patient csf sample on a cobas 8000 c 502 module.The initial result tested on the cobas c 502 was not provided and was accompanied by a data flag.The first repeated result tested on the cobas c 502 was 162 mg/l.A new sample was collected and sent to another laboratory to test with a nephelometer, and the results were not provided.Because the nephelometer results do not match the repeated results on the cobas c 502, the initial sample was re-tested on the cobas c 502.The second repeated result on the initial sample was 911 mg/l.It was alleged that the second cobas c 502 repeated results matched the nephelometer results.The reagent lot number was 63953401 and the expiration date was 31-aug-2023.
Additional Manufacturer Narrative
A general instrument or reagent problem could not be identified.Based on calibration and qc data a general reagent issue could be excluded.The cause of the event is consistent with sample quality issues.The investigation observed the existence of bubbles/foam on the surface of the sample.

• Brand Name: COBAS 8000 C 502 MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15692137
• Report Number: 1823260-2022-03400
• Device Sequence Number: 7300711
• Product Code: JJE
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K100853
• 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): 12/19/2022

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 Model Number: C502
• Device Catalogue Number: 05964067001
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/19/2022
• 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 Age: 50 YR
• Patient Sex: Male