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

Catalog Number	10825441001
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The k electrode lot number and expiration date were not provided.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ise results for 1 patient serum sample tested on a cobas pro ise analytical unit when compared to a different cobas pro ise analytical unit.Results for the potassium (k) test were affected.Initial result: 1.8 mmol/l.The customer questioned the initial result.No questionable result was reported outside the laboratory and the sample was repeated.Repeat result: 3.8 mmol/l (tested on another cobas pro).The repeat result was deemed to be correct.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, g1 and g4 were updated.The field service engineer found that the ise electrode needed more conditioning and a daily double green wash rack.Precision studies were performed and they were within specifications.The customer performed calibration and qc and they were acceptable.The service actions resolved the issue.No further issues were reported afterward.

• 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 46250-0457
• MDR Report Key: 19415080
• Report Number: 1823260-2024-01591
• Device Sequence Number: 6532582
• Product Code: CEM
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 07/17/2024
• 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 Catalogue Number: 10825441001
• Device Lot Number: ASKU
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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 Sex: Unknown