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

Model Number	C502
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the customer places serum and urine samples together on different racks on the sample tray on board the analyzer.Calibration data was acceptable and quality controls were ok on the day of the event.Upon review of the alarm trace from the day of the event, a sample clot and abnormal aspiration alarm were observed.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with crep2 creatinine plus ver.2 on a cobas 8000 c 502 module.The sample was initially processed on a cobas p 612 pre-analytics system prior to testing on the c 502 module.The patient sample initially resulted in a creatinine value of 215.8 umol/l and this value was reported outside of the laboratory.The patient was admitted based on the value.A creatinine measurement performed on the patient on (b)(6) 2022 was lower.The complained sample was then repeated on a second analyzer, resulting in a creatinine value of 77.0 umol/l.The sample was also repeated on a third analyzer, resulting in a value of 81.8 umol/l.The sample was then repeated on the complained analyzer, resulting in a value of 74.8 umol/l.The creatinine reagent lot number was 663665, with an expiration date of 30-jun-2023.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling.A general reagent problem can be ruled out as calibration and quality controls are acceptable.
Additional Manufacturer Narrative
The patient was tested again for creatinine on (b)(6) 2022 and the result was 99 umol/l.

• 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: 15938825
• Report Number: 1823260-2022-03931
• Device Sequence Number: 6219667
• Product Code: JJE
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 12/28/2022

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: 11/29/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 12/21/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/09/2022; 12/28/2022
• 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