MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CL ELECTRODE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number	03246353001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No electrode lot numbers with expiration dates were provided.The field service engineer (fse) found a pinched rinse tube.The customer ran qc, but the results were out of range.The fse performed instrument testing indicating all assays were within specification.The customer replaced the internal standard (is) reagent bottle, recalibrated, and ran qc.Qc was acceptable after replacing the is bottle.No issues were identified during a review of the alarm trace data.The service maintenance actions resolved the issue.
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient samples tested for sodium (na) and chloride (cl) on a cobas 6000 c (501) module.This medwatch will cover cl.Refer to medwatch with a1 patient identifier pt-83076 for information on the na results.Patient 1 initial na result was 120 mmol/l.The repeat result was 133 mmol/l.Patient 2 initial na result was 122 mmol/l.The repeat result was 132 mmol/l.Patient 2 initial cl result was 87.6 mmol/l.The repeat result was 97.1 mmol/l.The repeat results were believed to be correct.

• Brand Name: CL ELECTRODE
• Common Device Name: ELECTRODE, ION-SPECIFIC, CHLORIDE
• 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: 17515303
• Report Number: 1823260-2023-02608
• Device Sequence Number: 8104865
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2023

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: 03246353001
• 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: 07/25/2023
• Initial Report FDA Received Date: 08/11/2023
• 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 Age: 49 YR
• Patient Sex: Male