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

Catalog Number	10825441001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged non-reproducible potassium results for one patient's samples tested with the k electrode on cobas 8000 ise 900 module using lithium heparinized tubes when compared to results obtained in the hospital using dry tubes.The following results were obtained: laboratory, heparinized tube: 2.3 mmol/l and 2.4 mmol/l hospital, dry tube: 3.3 mmol/l and 3.5 mmol/l the customer ran a comparison between heparinized tubes and dry tubes from the same patient with the following results: 1st sample, dry tube: 3.9 and 4.0 mmol/l 2nd sample, heparinized tube: 3.7 and 3.7 mmol/l 3rd file, heparinized tube: 3.3 and 3.4 mmol/l the patient returned on (b)(6) 2023 and was measured with heparinized tubes resulting in values of 5.2 mmol/l and 5.0 mmol/l.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Precision studies were done and recovered within specifications.The patient was on chemotherapy treatment.Chemotherapy treatment may affect potassium.The investigation determined the issue was related to the patient sample.The investigation did not identify a product issue.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17362998
• Report Number: 1823260-2023-02370
• Device Sequence Number: 5152095
• Product Code: CEM
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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 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): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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: CHEMOTHERAPY
• Patient Sex: Unknown