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

Catalog Number	03246353001
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384); Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of analyzer alarms and questionable ise indirect gen 2 results from the cobas 6000 c 501 module.The initial chloride result was 6088.1 mmol/l and the repeat result was 100.1 mmol/l.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas 6000 c 501 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer found there was a failing electrode.The customer replaced the na and k electrodes, internal standard (is), diluent, and reference.The ise was primed and activated and ise checks were performed that were successful.Calibration and qc were performed and were successful.The investigation determined the service actions resolved the issue.

• 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: 17964232
• Report Number: 1823260-2023-03347
• Device Sequence Number: 15336054
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 01/23/2024

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: 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: 09/27/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/23/2024
• 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