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

Catalog Number	10825468001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 8000 ise module is (b)(6).The customer replaced the na electrode and reference electrode.The investigation is ongoing.
Event or Problem Description
The customer stated they received questionable ise results for approximately 19 patient samples tested on a cobas 8000 ise module.The samples were repeated and 11 sample results needed correction.The customer noted they replaced the ise electrodes and after this, all controls were outside of range.Ise checks were also failing.The customer tried running cleaning maintenance, conditioning the electrodes, replacing system reagents, and replacing the pinch valve tubing.The customer provided an example of one patient sample with discrepant na electrode results.The sample initially resulted in a na value of 133 mmol/l.Controls tested after the patient sample run were outside of range, so this prompted the customer to repeat the sample.The sample was repeated, resulting in a na value of 141 mmol/l.The repeat value was deemed correct.
Additional Manufacturer Narrative
Calibration and qc data prior to patient sample measurement were acceptable.The sample centrifugation speed may have been shorter than recommended by the tube manufacturer.Upon review of the alarm trace, an abnormal aspiration error was observed.This is an indicator of possible poor sample quality.The customer declined a service visit.The investigation determined the issue was resolved by the customer replacement of the na electrode and reference electrode.

• Brand Name: NA ELECTRODE
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• 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: 20171310
• Report Number: 1823260-2024-02600
• Device Sequence Number: 12513113
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 10/31/2024

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: 10825468001
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/31/2024
• 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: 46 YR
• Patient Sex: Female