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

Catalog Number	05860636001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c 501 (ul) v is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tpuc3 total protein urine/csf gen.3 results from urine patient samples tested on the cobas 6000 c 501 (ul) v.The reporter stated they failed a proficiency test prompting the rerun of the patient samples.The reporter was able to provide one example of discrepant results: the initial result was reported outside of the laboratory.The patient sample was sent to their other facility which uses a c8000 for the rerun.The initial result of the aliquot patient sample from the module was 41 mg/dl.The repeat result of the aliquot patient sample from the other laboratory's module was 21.8 mg/dl.The reporter is unsure which is the correct result.
Additional Manufacturer Narrative
Medwatch fields d.Device identification and g4 pma / 510k (premarket numbers) were updated.On the field service engineer's (fse) initial service visit, he inspected the module and replaced the reagent probes.He performed qc; the results were within range but were consistently at the lower end.The fse then referred the issue to the field application specialist (fas).On the fas's service visit, the fas noted that the issue was not resolved and the customer reported negative bias.The fas then verified the application parameters, calibration setpoints, special washes, and the data from the digital laboratory management software.The fas corrected the sample probe special wash and noted that data from the digital laboratory management software confirmed the negative bias.On the fse's follow-up service visit, he determined that the event was caused by aging parts in the system and contamination buildup.He then replaced the valve to the bath system and the aged tubing.He also replaced the missing ultrasonic mixer (usm) cover plate and decontaminated the bath and fluidic system.He verified the module's performance by qc with successful results; the qc recovery was close to the mean.The investigation reviewed the qc data; the qc recovery was within the provided ranges.The investigation reviewed the cumulative alarm trace; no issues were noted.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: 18302730
• Report Number: 1823260-2023-03935
• Device Sequence Number: 17876571
• Product Code: JJE
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 02/02/2024
• 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: 730111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/02/2024
• 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