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

Catalog Number	03111628180
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with the potassium electrode on a cobas b 221 analyzer (serial number (b)(4).The whole blood sample was tested on the cobas b 221 analyzer, resulting in a potassium value of 2.85 mmol/l.The a serum sample collected at the same time as the complained sample was tested on a cobas c 501 analyzer, resulting in a potassium value of 4.1 meq/l.The serum sample was repeated again on the c 501 analyzer on (b)(6) 2023, resulting in a value of 3.9 mmol/l.The result was corrected after repeat testing.
Additional Manufacturer Narrative
The potassium and reference electrodes were requested for the investigation, but these could not be provided.Data files from the analyzer which cover the day of the event also could not be provided.The potassium electrode was installed on (b)(6) 2022, with an in-use time of 23 weeks.The electrode was valid until (b)(6) 2022, which would make the electrode invalid at the time of the event.Higher potassium concentrations are to be expected in serum compared to whole blood samples.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: POTASSIUM 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16489549
• Report Number: 1823260-2023-00695
• Device Sequence Number: 15164566
• Product Code: CEM
• UDI-Device Identifier: 04015630014293
• UDI-Public: 04015630014293
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K032311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: 12/30/2022
• Device Catalogue Number: 03111628180
• Device Lot Number: 21522647
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ALBUMIN; BICARBONATE AND HEPARIN PUMP; HYDROCORTISONE; OMEPRAZOLE; PARACETAMOL; PIPERACILLIN; VANCOMYCIN
• Patient Sex: Unknown