MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05171873190
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	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ureal reagent lot number is 711808 with an expiration date of 31-jan-2024.The crp4 reagent lot number is 714911 with an expiration date of 31-mar-2024.The calibration and qc data provided was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ureal urea/bun and crpl3 c-reactive protein gen.3 results for 3 patient samples on a cobas 8000 c702 module.On (b)(6) 2023, the initial ureal result from line b for sample 1 was 0.6 mmol/l.The repeat result from line b was 20.0 mmol/l.(b)(6) 2023, the sample was repeated on line a and the result was 19.9 mmol/l.On (b)(6) 2023, sample 2 had an initial crp4 result of 0.01 mg/dl.The repeat result was 0.34 mg/l.On (b)(6) 2023, sample 3 had an initial ureal result of 0.8 mmol/l.The repeat result was 11.5 mmol/l.Clarification on which lines samples 2 and 3 were run on was not provided.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The field service engineer (fse) performed precision testing and carryover checks successfully and observed bacterial growth in the black water tank.The root cause of the event was found to be consistent with contamination.

• Brand Name: COBAS 8000 C 702 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17663171
• Report Number: 1823260-2023-02843
• Device Sequence Number: 6207602
• Product Code: JJE
• UDI-Device Identifier: 04015630925131
• UDI-Public: 04015630925131
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K972250
• 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): 11/16/2023

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 Catalogue Number: 05171873190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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