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	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.The customer's calibration and qc results were ok.There was no indication of a reagent issue.The investigation reviewed the system's alarm trace and multiple abnormal aspiration alarms were observed, which may indicate poor sample quality.The investigation found the spring holder was holding down the rinse nozzle on the rinse head out of position and the rinse nozzle was not springing down into the cuvettes.The field service representative replaced the spring holder and spring, cleaned the rinse nozzle, and confirmed proper springing of the rinse nozzle.He replaced the mixers and performed hardware checks by assay performance with passing results.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of multiple questionable ca2 results on a cobas 8000 c 701 module.The customer provided results for 2 patient samples.Results from sample 1: the initial result was 5.37 mg/dl.The repeated results were 9.42 mg/dl and 9.58 mg/dl.The repeated results were obtained using 2 other c701 modules.The result of 9.42 mg/dl was believed to be correct.Results from sample 2: the initial result was 6.23 mg/dl.The repeated result was 9.83 mg/dl.The repeated result was obtained using another c701 module.The repeated result was believed to be correct.The erroneous results were not reported outside of the laboratory due to being held as critical/panic values.

• 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: 18438512
• Report Number: 1823260-2024-00018
• Device Sequence Number: 7023820
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 01/03/2024

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: 12/15/2023
• Initial Report FDA Received Date: 01/03/2024
• 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