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

Catalog Number	04404483190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample tested with sodium (na) test and 1 patient's serum sample tested with na test and glucose hk gen.3 (gluc3) assay on a cobas 6000 c501 analyzer.Sample 1: na: initial result: 165 mmol/l.Repeat result: 140 mmol/l.Sample 2: na: initial result: 150 mmol/l.Repeat result: 141 mmol/l.Gluc3: initial result: 42 mg/dl.Repeat result: 106 mg/dl.The medical personnel questioned the initial results and requested the samples be repeated.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The na electrode lot number and expiration date were not provided.The gluc3 reagent lot number was 74348401.The expiration date was not provided.The field service engineer found that the rinse vacuum line was ripped at the nozzle.He repaired the vacuum line and inspected the rinse tubing and the rinse levels.The customer performed qc and mechanical checks and they were successful.Precision studies were performed and they were within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
Section d4 was updated.Correction: sample 1 and sample 2 were plasma samples.The glucose calibration was last performed on (b)(6) 2023 and it was acceptable.The sodium calibration was performed on (b)(6) 2024 and it was acceptable.Qc recovery was within the range.No indication of a performance issue with the reagent.The service action (repairing the vacuum line and inspecting the rinse tubing and the rinse levels) resolved the issue.No further issues were reported afterward.

• 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: 18913316
• Report Number: 1823260-2024-00772
• Device Sequence Number: 20514083
• Product Code: JJE
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 04/03/2024

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): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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