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

Catalog Number	05168449190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ca2 calcium gen.2 results from two patient samples tested on the cobas 8000 cobas c 701 module.The initial results were not reported outside of the laboratory as they were deemed too low, prompting the rerun of the patient samples.Sample id (b)(6): on (b)(6) 2023, the initial result from the module was 5.0 mg/dl.The repeat result from the module was 9.0 mg/dl.This result was deemed correct.Sample id (b)(6): the patient sample was also rerun on another module.On (b)(6) 2023, the initial result from the module was 7.2 mg/dl.The first repeat result from the module upon auto-repeat was 6.0 mg/dl.The second repeat result from the other module was 8.2 mg/dl.This result was deemed correct.
Additional Manufacturer Narrative
The reagent lot number is 694033.The expiration date was requested but not provided.The field service engineer inspected the module and found that one of the vacuum vessels was filling with fluid causing issues with cell cleaning.He then cleaned the vacuum flow path, the drain waste elbow, and the waste manifold.He verified the module's vacuum vessel's waste evacuation performance by mechanism checks with successful results.He performed a precision check with successful results.The investigation reviewed the last calibration performed on 08-aug-2023 and 11-aug-2023; the results were within specifications.The investigation reviewed the qc recovery; numerous flags were noted.The investigation was unable to determine if the qc was out of range as there were no specific ranges and standard deviation (sd) values provided.The investigation reviewed the alarm trace.Multiple abnormal aspiration alarms on both sample probes a and b were found.There was also an alarm regarding the water reservoir level being too low.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• 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 46250-0457
• MDR Report Key: 17709828
• Report Number: 1823260-2023-02923
• Device Sequence Number: 2149118
• Product Code: JJE
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113521
• 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): 09/08/2023

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: 05168449190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/08/2023
• 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 Age: 42 YR
• Patient Sex: Female