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

Catalog Number	10825468001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect na and k for gen.2 results from multiple samples tested on the cobas 6000 c 501 (ul) v.The reporter stated that some questionable initial results were reported outside of the laboratory and the low anion gaps prompted the rerun of patient samples.The reporter was able to provide two patient samples with discrepant results: sample id 0423:c02503s: the initial na result was 120 mmol/l.The repeat result was 139 mmol/l.Sample id 0423:c02514s: the initial na result was 127 mmol/l.The repeat result was 138 mmol/l.
Additional Manufacturer Narrative
The electrode lot number and its expiration date were requested but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field d4 lot no was updated.The serial number of the cobas 6000 c501 (ul) v is (b)(6).The field service engineer (fse) inspected the module and did not find a specific cause for the event.He then preventatively replaced all the components to the ion-selective electrode (ise) measuring system and aligned the sipper nozzle and ise reagent probe.Calibrations, qcs, and a 21-replicate precision test using control material were performed with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions verified the module's performance.

• 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: 19393129
• Report Number: 1823260-2024-01555
• Device Sequence Number: 15403616
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 07/15/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/15/2024
• 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: 37 YR
• Patient Sex: Unknown