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

Catalog Number 03111628180

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Na.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 310790847
• Report Number: 1823260-2023-00695
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 04015630014293
• UDI-Public: 04015630014293
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUMIN; BICARBONATE AND HEPARIN PUMP; HYDROCORTISONE; OMEPRAZOLE; PARACETAMOL; PIPERACILLIN; VANCOMYCIN