MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PRO ISE ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	08464537001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable ise results for 1 patient's serum sample tested on a cobas pro ise analytical unit when compared to a different analyzer.Results for the following tests were affected: sodium (na) and chloride (cl).Na: initial result: 152.6 mmol/l.Repeat result: 138 mmol/l (tested on another analyzer).Cl: initial result: 112.7 mmol/l.Repeat result: 100.8 mmol/l (tested on another analyzer).Since the initial results did not match the point of care (poc) results, the samples were then repeated.
Additional Manufacturer Narrative
The na reagent lot number was r5857.The expiration date was not provided.The cl reagent lot number and expiration date were not provided.Calibration and qc were performed and they were acceptable.On the day of the event, the alarm trace showed multiple alarms including sample probe: abnormal aspiration alarms and abnormal aspiration alarms.This is consistent with a poor sample quality.The field service engineer (fse) found the sample probe and the sipper probe were defective.He also found that the tubing was stretched behind the valves.The fse replaced the sample and sipper probes and corrected the tubing.He also performed the necessary alignments by checking the electrode seating, the o-rings, the reagent straws, and the filter.The fse corrected the tubing behind the valve.The fse then ran purges, primes, and checks, and they were all successful.Calibration was performed and it was acceptable.The fse did a performance check and the instrument was performing within specifications.The cause was due to defective sample and sipper probes and stretched tubing behind the valves.The service action (replacing the sample and sipper probes and correcting the tubing) resolved the issue.No further issues were reported afterward.

• Brand Name: COBAS PRO ISE ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18660852
• Report Number: 1823260-2024-00360
• Device Sequence Number: 8002369
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191899
• 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
• Report Date (Section B): 02/07/2024

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: 08464537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/07/2024
• 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