MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the bilt3 (bilirubin total gen.3) assay on a cobas 6000 c501 module.The sample initially resulted in a bilt3 value of 0.39 mg/dl.The initial value was reported outside of the laboratory and questioned by a physician.The patient sample was repeated, resulting in a bilt3 value of 14.91 mg/dl.The re-measurement was done on the same sample, supplemented with plasma.The bilt3 reagent lot number was 633563 with an expiration date of 30-nov-2023.
Additional Manufacturer Narrative
Additional discrepant bilt3 and bild2 (bilirubin direct gen.2) results were received for another patient sample (patient 2).On (b)(6) 2022, patient sample 2 initially resulted in a bilt3 value of 0.38.The sample was repeated two times, resulting in values of 0.01 and 0.79.On (b)(6) 2022, patient sample 2 initially resulted in a bild2 value of 0.00.The sample was repeated two times, resulting in bild2 values of 0.86 and 0.84.No units of measure were provided.No questionable results were reported outside of the laboratory.The bild2 reagent lot was 670814 with an expiration date of 31-jan-2024.For patient sample 1, calibration results were within specification.The investigation found imprecision with the customer¿s third-party quality control results, possibly indicating sample handling issues.The reaction kinetic was requested but could not be provided.For patient sample 2, the reaction kinetic for bild2 shows zero pipetting first, and the reruns show no endpoint reaction, which possibly indicates a gammopathy or sample handling issue.Product labeling states: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results." for patient sample 2, no reaction kinetic for bilt3 was provided as well as no calibration and quality control data.The investigation did not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: COBAS 6000 C501 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: 15799853
• Report Number: 1823260-2022-03633
• Device Sequence Number: 3113883
• Product Code: JJE
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K060373
• 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): 01/04/2023

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: C501
• Device Catalogue Number: 04745914001
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/04/2023
• 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