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

Catalog Number	03246353001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na and cl electrodes' lot numbers and expiration dates were not provided.Qc was acceptable on the day of the event prior to the sample measurement.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ise results for 1 patient sample tested on a cobas 6000 c (501) module when compared to an integra 400 plus analyzer.Results for the following tests were affected: sodium (na) and chloride (cl).Na: initial result: 123 mmol/l.Repeat result: 137 mmol/l (tested on integra 400 plus).Cl: initial result: 81.7 mmol/l.Repeat result: 95 mmol/l (tested on integra 400 plus).The initial results were reported outside the laboratory and they did not match the patient's history.The sample was then repeated and the repeat results were deemed to be correct.Reportedly, the customer called the physician and corrected the results.
Additional Manufacturer Narrative
The patient sample was a serum sample.The calibration was last performed on 16-sep-2024 and it was acceptable.There was no indication of a performance issue with the reagent since the qc was acceptable.The sample centrifugation time may have been shorter than recommended by the tube manufacturer.The alarm trace showed no abnormality.The field service engineer (fse) visited the customer's site twice.During the 1st visit, he found that the electrodes were defective.The customer replaced the electrodes and performed precision studies and they were within specifications.During the 2nd visit, he found that the ise unit was contaminated.He performed decontamination of the ise unit and conditioned the tubing and the electrodes.Precision studies were performed and they were within specifications.The fse found that the cause was due to defective electrodes and contamination of the ise unit.The service actions 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: 20409088
• Report Number: 1823260-2024-02930
• Device Sequence Number: 7920569
• Product Code: JJE
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 11/14/2024

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: 03246353001
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/14/2024
• 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: 46 YR
• Patient Sex: Male