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

Catalog Number	03003523001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas integra 400 plus is (b)(6).The field service engineer (fse) inspected the analyzer and noted the following: the cleaner float switch was not working properly, potentially causing imprecise pipetting of the probe; the cleaner bottle was empty but was not flagged by the system; and the pinch valve in the ion-selective electrode (ise) module was malfunctioning causing the ise calibrators not to prime properly.He then replaced the cleaner bottle, cleaned the ise pinch valves, and reseated the tubing.He performed ise primes, ise calibrations, and qc with successful results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ise indirect ci for gen.2 results from 20 patient samples tested on the cobas integra 400 plus.The initial results were not reported outside of the laboratory.The reporter noted that the cl results were running high compared to the patient history prompting the rerun of the patient samples.The reporter was able to provide two examples of discrepant results: sample 1 the initial cl result was 122 mmol/l.The repeat result was 105 mmol/l.Sample 2 the initial cl result was 118 mmol/l.The repeat result was 106 mmol/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
After service, no further issues were reported by the customer.The investigation determined the service actions 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18693992
• Report Number: 1823260-2024-00412
• Device Sequence Number: 8509365
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 03/26/2024

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 Expiration Date: 01/12/2024
• Device Catalogue Number: 03003523001
• Device Lot Number: 31233047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/26/2024
• 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