MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04810716190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 718697.The expiration date was requested but not provided.The field service engineer (fse) inspected the module and identified the rinse mechanism tubing as the cause of the issue.He then replaced this part.The investigation reviewed the last calibration performed on (b)(6) 2023.The results were within specifications.The investigation reviewed the qc recovery.The qc recovery was within -2 standard deviations (sd) and was within specifications.There is no indication of a performance issue with the reagent.The investigation reviewed the alarm trace.There was an abnormal aspiration alarm noted on the date of the event close to the time the patient sample was processed.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 a questionable crep2 (creatinine plus ver.2) result from one patient sample tested on the cobas 8000 cobas c 502 module.The initial result was reported outside of the laboratory.The physician questioned the result as it did not match the patient's clinical condition, prompting the rerun of the patient sample.A new sample was also collected from the patient.The initial result of the initial sample was 4.02 mg/dl.The repeat result of the initial sample was 0.54 mg/dl.The result of the new sample was 0.52 mg/dl.The repeat result was deemed correct.

• Brand Name: COBAS 8000 C 502 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: 17720353
• Report Number: 1823260-2023-02946
• Device Sequence Number: 12567534
• Product Code: JJE
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K941837
• 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): 09/11/2023

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: 04810716190
• Device Lot Number: 718697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/11/2023
• 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: 21 YR
• Patient Sex: Female