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	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for samples from one patient tested with hapt2 (tina-quant haptoglobin ver.2) assay on a cobas 8000 c 502 module.The first sample initially resulted in a hapt2 value of 0.02 g/l.24 hours later, the sample was repeated twice, resulting in values of 4.76 g/l and 4.95 g/l.On (b)(6) 2022, a second sample from the same patient was measured.The sample initially resulted in a hapt2 value of 4.77 g/l.The sample was repeated three times, resulting in values of 4.92 g/l, 4.76 g/l and 4.82 g/l.The initial questionable low result was reported outside of the laboratory.The reagent lot was 642662 with an expiration date of 31-mar-2024.
Additional Manufacturer Narrative
The reaction monitor of the initial low result shows an abnormal kinetic.Calibration results showed frequent errors.Quality control results were not provided.Upon review of the alarm trace, "sample foam", "sample clot", "sample duplicate" and "abnormal aspiration" errors were observed.Based on the information provided it is not clear if the centrifugation terms are correctly performed according to the tube manufacturer's instructions.No rack adapters were used.The customer uses several third-party reagents on the analyzer.The investigation could not identify a product problem.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.

• 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: 15920590
• Report Number: 1823260-2022-03874
• Device Sequence Number: 4384381
• Product Code: JJE
• UDI-Device Identifier: 04015630916580
• UDI-Public: 04015630916580
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/13/2023

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: 11/10/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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