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

Model Number	C701
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer found the cell blank water was overflowing the reaction cells.He adjusted all the rinse mechanism cell rinse discharge volumes and performed a hardware check that was successful.The customer performed calibration and qc that passed.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable calcium gen.2 result from the cobas 8000 cobas c 701 module.Sample 1 original result was 5.2 mg/dl and the repeat result was 9.4 mg/dl.Sample 2 original result was 5.6 mg/dl and the repeat result was 9.7 mg/dl.Sample 3 original result was 5.9 mg/dl and the repeat result was 8.5 mg/dl.The questionable results were reported outside of the laboratory.The repeat results were believed correct.The regent lot number was 693360.The expiration date was requested but was not provided.

• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16954428
• Report Number: 1823260-2023-01666
• Device Sequence Number: 20586166
• Product Code: JJE
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: C701
• Device Catalogue Number: 05641489001
• 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: 05/01/2023
• Initial Report FDA Received Date: 05/18/2023
• 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