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

Catalog Number	03003523001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high results for 4 patient samples tested for chloride electrode (cl) on a cobas integra 400 plus.Discrepant results were provided for 1 patient sample.The initial result was 138 mmol/l.The sample was repeated 3 times with results of 119 mmol/l, 126 mmol/l, and 239 mmol/l.The customer did not know which result was correct.The results for this patient were not reported outside of the laboratory.
Additional Manufacturer Narrative
The integra 400 plus serial number was (b)(6).The customer was also having qc issues.Calibration was last performed on (b)(6) 2023 with acceptable results.On the day of the event, qc was within the acceptable ranges at 7:28 a.M.The customer repeated qc multiple times between 1:00 p.M.And 2:00 p.M.And the results were outside of the acceptable ranges.The field service engineer (fse) found the issue was due to the cl electrode.The cl electrode was replaced.The fse confirmed all mechanisms were working properly and qc was acceptable.The maintenance actions (replacing the electrode) resolved the issue.

• 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: 17376138
• Report Number: 1823260-2023-02412
• Device Sequence Number: 6506866
• 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): 07/23/2023

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: 07/05/2023
• Initial Report FDA Received Date: 07/24/2023
• 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: 58 YR
• Patient Sex: Female