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

Model Number	C501
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the acet2 (online tdm acetaminophen gen.2) assay on a cobas 6000 c501 module.The sample initially resulted in an acet2 value of 35.6 umol/l and repeated as 501.6 umol/l the following day.The repeat result was deemed correct.No questionable result was reported outside of the laboratory.The acet2 reagent lot was 59848101 with an expiration date of 30-apr-2023.
Additional Manufacturer Narrative
Several alarms related to sample clots and sample short were noted.The investigation is ongoing.
Additional Manufacturer Narrative
The customer used 13 mm.Diameter tubes, but did not use rack adapters required for 13 mm.Tubes.Based on the provided information it cannot be determined if the clotting time for the sample was adequate and should be checked with the tube manufacturer¿s recommendations.The field service engineer checked the analyzer and found issues with different parts of the instrument like the gear pump and the valves of acid wash.He fixed the issues and completed instrument performance testing with acceptable results.The investigation determined the service actions performed resolved the issue.

• 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: 16023876
• Report Number: 1823260-2022-04135
• Device Sequence Number: 5785228
• Product Code: JJE
• UDI-Device Identifier: 04015630935031
• UDI-Public: 04015630935031
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 01/23/2023

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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/23/2023
• 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