MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05860636001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable dig digoxin results from one patient sample tested on the cobas 6000 c 501 (ul) v.The initial result was reported outside of the laboratory.Calibration and qc issues prompted the rerun of the patient sample.The initial result was 1.04 ng/ml.The first repeat result was 0.55 ng/ml.The second repeat result was 0.92 or 0.94 ng/ml.The third repeat result was 0.62 ng/ml.No result was deemed correct.
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c501 (b)(6).The field service engineer (fse) inspected the module and determined the event was due to high blank cell measurements.He then performed a complete preventive maintenance procedure.He verified the instrument's performance by calibration, qc and a 21-cup precision check.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2024 and alarms were present.The investigation reviewed the qc recovery.The qc was initially out of range on the date of event but was in range after several reruns.The investigation reviewed the alarm trace and several alarms were noted (procell/cleancell short, abnormal probe sucking and movement, calibration errors, tip-assay cup movement, and bath water level sensor alarms).After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2024 and alarms were present.The investigation reviewed the qc recovery.The qc was initially out of range on the date of event but was in range after several reruns.The investigation reviewed the alarm trace and several alarms were noted (procell/cleancell short, abnormal probe sucking and movement, calibration errors, tip-assay cup movement, and bath water level sensor alarms).After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C (501) 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: 19605379
• Report Number: 1823260-2024-01853
• Device Sequence Number: 8044418
• Product Code: JJE
• UDI-Device Identifier: 04015630915682
• UDI-Public: 04015630915682
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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,Followup
• Report Date (Section B): 08/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 05860636001
• Device Lot Number: 700903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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: Male