MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05641489001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and the expiration date were requested but not provided.The field service engineer inspected the module and found the rinse tubing in rinse mechanism 1 damaged and cuvette rinse water on top of the cuvettes.He then replaced the rinse tubing and checked the rinse assembly adjustments and water volumes.The customer performed calibrations and qcs with acceptable results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable ca2 calcium gen.2 results from six patient samples tested on the cobas 8000 cobas c 701 module.The initial results were reported outside of the laboratory.The reporter stated that the qc became out of range prompting the rerun of the previously reported patient samples on their two other unspecified analyzers.The reporter was able to provide two examples of questionable results: sample 1: the initial result from the module was 7.7 mg/dl with a data flag "l".The repeat result from the other analyzer was 9.7 mg/dl.Sample 2: the initial result from the module was 7.6 mg/dl with a data flag "l".The repeat result from the other analyzer was 9.6 mg/dl.The repeat results were deemed correct. .

• Brand Name: COBAS 8000 C 701 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
• MDR Report Key: 18256543
• Report Number: 1823260-2023-03829
• Device Sequence Number: 7191596
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

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 Catalogue Number: 05641489001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/04/2023
• 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