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

Catalog Number	10825441001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The was an allegation of a questionable ise indirect gen 2 potassium result from the cobas 8000 cobas ise module.Another customer site had issues with questionable potassium results for one patient.The result from a siemens analyzer was 4.0 mmol/l.An aliquot of the sample was tested on one of the cobas 8000 cobas ise modules at that customer's site and the results were 4.0 mmol/l and 6.4 mmol/l.The customer then tested the sample on all four cobas modules and the results were between 6.4 - 6.5 mmol/l with a data flag.The sample was then tested at this laboratory on the cobas 8000 cobas ise module and the result was 5.0 mmol/l.The result from this analyzer was not reported outside of the laboratory.The result from a siemens analyzer of 4.0 mmol/l was believed correct.
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Based on the data provided, a clear root cause could not be identified.With the limited amount of information, the investigation was unable to rule out possible causes.

• 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: 17977441
• Report Number: 1823260-2023-03381
• Device Sequence Number: 19700597
• Product Code: CEM
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 01/24/2024

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: 10825441001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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: 69 YR
• Patient Sex: Female