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	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable crep2 (creatinine) result from one patient sample tested on the cobas 8000 cobas c 701 module.The initial result was not reported outside of the laboratory.The patient sample was rerun on two other analyzers: analyzer a and analyzer b.The initial result from the module was 143 umol/l.The first repeat result from the module was 293 umol/l.The second repeat result from analyzer a was 303 umol/l.The third repeat result from analyzer b was 285 umol/l.This was the reported result.
Additional Manufacturer Narrative
The reagent lot number is 75442501.The expiration date is 31-jul-2024.On the field service engineer's (fse) first service visit, he found an obstruction in the probe wash station.The fse then decontaminated the reagent and sample lines, changed the gear pump gear, adjusted the cell rinse level, decontaminated the lines, dismantled a rinse station and repaired the needle hose.On the fse's second service visit, he checked the valve and the rinse, replaced the valves, checked the volumes, bleached the valves, and refitted the tubing.On the fse's third service visit, he found a vacuum problem in the degasser.He then replaced the degasser and adjusted the level of the cuvettes.He also bleached the vacuum bottle, replaced parts, and performed adjustments, he performed mechanical checks with successful results.The investigation determined the event was caused by insufficient maintenance.After the final service visit, 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
• MDR Report Key: 18468969
• Report Number: 1823260-2024-00085
• Device Sequence Number: 19608083
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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: 12/21/2023
• Initial Report FDA Received Date: 01/08/2024
• 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