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

Catalog Number	10825468001
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pro ise analytical unit is (b)(6).The investigation is ongoing.The field service engineer (fse) investigated the event and determined that the calibrations and qcs were valid that it was a single questionable patient sample result and that all the other results had no issues.The customer stated that they suspected a patient sample issue.He then manually cleaned and verified the ion-selective electrode (ise) unit and its adjustments and performed a daily wash rack, ise checks, calibrations, and qcs.He verified that the module was performing within specifications.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable ise indirect na for gen.2 result from one patient sample tested on the cobas pro ise analytical unit the initial result was not reported outside of the laboratory.The result from a second patient sample was different prompting the rerun of the initial patient sample.The initial na result was 112.9 mmol/l.The repeat result was 135.3 mmol/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 19749175
• Report Number: 1823260-2024-02040
• Device Sequence Number: 18396176
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 08/05/2024

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: 06/20/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/05/2024
• 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 Sex: Unknown