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

Catalog Number	05860636001
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2024
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 field service engineer (fse) inspected the module and found that the water tank was cracked and the water tank and internal supply were contaminated.He then performed decontamination and adjusted the rinse levels to the correct specification.He verified the module's performance by a 21-cup precision test using qc level 2 material with successful results.The customer performed qc with successful results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable calcium (ca, gen.2) results from seven patient samples tested on the cobas 6000 c 501 (ul) v.The initial results were not reported outside of the laboratory.The results failed delta checks prompting the rerun of the patient samples on their other c 501.The reporter was able to provide the following examples of discrepant results: sample 1 the initial result from the module was 5.0 mg/dl.The repeat result from the other module was 8.1 mg/dl.Sample 2 the initial result from the module was 6.5 mg/dl.The repeat result from the other module was 8.4 mg/dl.Sample 3 the initial result from the module was 6.5 mg/dl.The repeat result from the other module was 9.1 mg/dl.Sample 4 the initial result from the module was 7.2 mg/dl.The repeat result from the other module was 8.9 mg/dl.Sample 5 the initial result from the module was 7.5 mg/dl.The repeat result from the other module was 9.1 mg/dl.The repeat results were deemed correct. .
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation confirmed that the customer¿s water system underwent maintenance activities before the event.The module's water requirements are within the customer¿s responsibility and are covered in product labeling.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: 18594580
• Report Number: 1823260-2024-00242
• Device Sequence Number: 11688224
• Product Code: JJE
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• 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): 02/21/2024
• 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: 752918
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/21/2024
• 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 Age: 24 YR
• Patient Sex: Male