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	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial numbers were (b)(6).The customer declined a service visit for this issue.Scheduled preventive maintenance was performed and no issues were found.All electrodes were replaced and ise checks passed.Precision testing was performed and was within specification.The analyzer alarm trace contained abnormal aspiration alarms around the time of the event.This may be an indication of poor sample quality.
Event or Problem Description
The was an allegation of questionable ise indirect gen 2 potassium results from cobas 8000 cobas ise modules.At 0800, the result for the patient was 6.7 mmol/l with a data flag.The sample was tested on two other cobas analyzers and the result was the same the result was reported outside of the laboratory to the doctor who had the patient go to the hospital er.The result from a new sample using a siemens analyzer was 4.0 mmol/l.On (b)(6) 2023, the first sample was retested on three cobas ise units in the laboratory.All results were 6.7 mmol/l.The sample was sent to two reference laboratories and the results were 7.0 and 6.5 mmol/l.An aliquot of the second sample drawn at the er was tested on the cobas 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 tested at a different reference laboratory and the result was 5.0 mmol/l.The results obtained at the hospital er were believed correct.
Additional Manufacturer Narrative
A comparison study was performed between the customer's analyzer and an analyzer at a reference site and the results were acceptable.The customer confirmed they have had no further issues.The investigation did not identify a product problem.The specific 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: 17969665
• Report Number: 1823260-2023-03366
• Device Sequence Number: 7754456
• 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 Expiration Date: 08/06/2024
• Device Catalogue Number: 10825441001
• Device Lot Number: X4936
• 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: 10/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALLOPURINOL,; ALPRAZOLAM,; AMLODIPINE,; CEPHALEXIN,; DECITABINE.; DOXYCYCLINE HYCLATE,; ESCITALOPRAM OXALATE,; FLUCONAZOLE,; FLUTICASONE PROPRIONATE,; HYDROXYUREA,; METRONIDAZOLE,; ONDANSETRON HCL,; PIMECOLIMUS,; ROSUVASTATIN,; SIMVASTATIN,; TELMISARTAN,; TOBRAMYCIN-DEXAMETHASONE,; VENETOCLAX,
• Patient Age: 69 YR
• Patient Sex: Female