MAUDE Adverse Event Report: ROCHE DIAGNOSTICS K ELECTRODE; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number	10825441001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c303 analytical unit serial number was (b)(6).Qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ise results for 1 patient plasma sample tested on a cobas c303 analytical unit.Results for the potassium (k) test were affected.Initial result: 6.06 mmol/l.The physician questioned the initial result.The patient went to the er for the new sample collection which resulted in a k value of 3.9 mmol/l.The customer then repeated the original sample on the same analyzer and the repeat result was 4.30 mmol/l.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The calibration was last performed on (b)(6) 2024 and it was acceptable.The pre-analytical data showed that the provided spin speed might be faster than recommended.The alarm trace did not show any abnormality.The field service engineer found that the issue was due to the patient sample.He performed ise checks, cleaned the electrode, and verified no issues were present.Upon follow-up, the customer confirmed that the issue was isolated to one sample and no further issues were reported after the service visit.Additional details regarding the sample were not available.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: K ELECTRODE
• Common Device Name: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19810802
• Report Number: 1823260-2024-02127
• Device Sequence Number: 18016498
• Product Code: CEM
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• 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): 08/15/2024

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 Expiration Date: 03/23/2025
• Device Catalogue Number: 10825441001
• Device Lot Number: G3078
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEVOTHYROXINE; LISINOPRIL; METFORMIN; NAPROXEN SODIUM; PIOGLITAZONE; SIMVASTATIN
• Patient Age: 77 YR
• Patient Sex: Female