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

Catalog Number	05860636001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c501 (ul) v module 1 is (b)(6).The serial number of the customer's cobas 6000 c501 (ul) v module 2 is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable trigl triglycerides results from an estimated minimum of 50 patient samples tested on two cobas 6000 c501 (ul) v (module 1 and module 2).The reporter was able to provide one patient sample with discrepant results: the initial result was not reported outside of the laboratory.The reporter stated that the qc would not pass and there was a high number of patient sample results with an invalidating data flag or very low results, prompting the rerun of previous patient samples on their other c501 module.The reporter stated that they noticed the issue after service was performed on their deionized (di) water system.The initial result from module 1 was 153 mg/dl.The repeat result from module 2 was 212 mg/dl.The repeat result could not be determined as both analyzers were affected by the water source issue.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The field service engineer (fse) inspected the module and determined the event was caused by resistivity high on the water system.The fse flushed the water system and recalibrated the assay.The customer performed qcs with acceptable results.The investigation noted that the customer¿s water system underwent maintenance activities before the event.Water requirements are within the customer¿s responsibility.The investigation determined the event was consistent with mishandling (customer's water system maintenance).The investigation did not identify a product problem.

• 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: 18977097
• Report Number: 1823260-2024-00898
• Device Sequence Number: 20386846
• Product Code: JJE
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 05/09/2024
• 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 Expiration Date: 09/30/2024
• Device Catalogue Number: 05860636001
• Device Lot Number: 74902501
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/09/2024
• 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