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

Catalog Number	04404483190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glucose reagent lot number is 73288001 and the expiration date is 31-aug-2024.The other reagent and electrode lot numbers and expiration dates were not provided.Calibration was last performed on (b)(6) 2023.The qc recovery data provided was acceptable.The field service engineer (fse) found that the rinse mechanism squeegee nozzle was hitting cells during the rinse mechanism operation.The fse adjusted and replaced the mechanism nozzles, adjusted the gear pump pressure, confirmed appropriate vacuum pump function, and performed a hardware check and precision check successfully.The customer performed qc successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable gluc3 glucose hk gen.3, hdlc3 hdl-cholesterol plus 3rd generation, gen.2 ise indirect for na and k results for 1 patient sample on a cobas 6000 c (501) module.The initial glucose result was 108 mg/dl, the initial hdl result was 12 mg/dl, the initial k result was 6.00 mmol/l, and the initial na result was 160 mmol/l.The customer noticed data flags on some of the other test results which prompted them to repeat the sample.The sample was repeated on another analyzer and the repeat glucose result was 87 mg/dl, the repeat hdl result was 52 mg/dl, the repeat k result was 4.34 mmol/l, and the repeat na result was 140 mmol/l.
Additional Manufacturer Narrative
The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 18346980
• Report Number: 1823260-2023-04069
• Device Sequence Number: 12103931
• Product Code: JJE
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061048
• 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): 01/08/2024

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: 04404483190
• 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: 11/22/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/08/2024
• 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 Age: 67 YR
• Patient Sex: Female