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

Catalog Number	03003523001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer found the chloride electrode needed replacement.He checked the ise system and observed no issues, performed an ise performance check and all passed, and replaced the mixing tower.The customer changed the electrode and ran qc with results within the specified ranges.The investigation determined the service actions resolved the issue.H3 other text : na.
Event or Problem Description
There was an allegation of questionable ise indirect gen chloride results from cobas integra 400 plus analyzer serial number (b)(6).Sample 1 initial result was 141 mmol/l and was reported outside of the laboratory.The doctor called questioning the result.The repeat result was 109 mmol/l.On (b)(6) 2023, sample 2 initial result was 136 mmol/l and the repeat result was 108.The questionable result for this sample was not reported outside of the laboratory.The repeat results were believed correct.

• Brand Name: CHLORIDE 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16896505
• Report Number: 1823260-2023-01556
• Device Sequence Number: 14987529
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (Y/N): N
• 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): 05/09/2023

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 Expiration Date: 06/23/2023
• Device Catalogue Number: 03003523001
• Device Lot Number: 21530147
• 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: 04/25/2023
• Initial Report FDA Received Date: 05/09/2023
• 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