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

Catalog Number	21029371001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot number is 16774.The expiration date was requested but not provided.The customer used a new internal standard with a new lot number.The customer stated that this resolved the issue as the qc and patient results became higher.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from an unspecified number of patient samples tested on the cobas 6000 c (501) module.The initial results were reported outside of the laboratory.The reporter stated the sodium patient results were low and that some doctors questioned the results which prompted the rerun of the patient samples.They stated that qc was within range but about -1 standard deviation.The difference between the initial and repeat results was reportedly 7 to 8 mmol/l with one result difference as high as 10 mmol/l.The reporter stated they had to issue 32 corrected reports.The reporter was able to provide one example of a discrepant result.The reporter stated that the repeat result may have been from their other analyzer.The initial sodium result from the module was 126 mmol/l.The repeat result which may have been from their other analyzer was 134 mmol/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
The investigation determined the customer's actions resolved the issue.

• Brand Name: SODIUM 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; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3174767531
• MDR Report Key: 17316901
• Report Number: 1823260-2023-02243
• Device Sequence Number: 17161307
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963627
• 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): 08/25/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/30/2024
• Device Catalogue Number: 21029371001
• Device Lot Number: 70703701
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/25/2023
• 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
• Patient Sex: Unknown