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

Catalog Number	08464537001
Medical Device Problem Codes	Mechanical Problem (1384); Unable to Obtain Readings (1516); 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	02/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from eleven patient samples tested on the cobas pro ise analytical unit.The reporter was able to provide one example of a discrepant result.The initial result was reported outside of the laboratory.The initial result was flagged with a delta check in the laboratory information system (lis) prompting the rerun of the patient sample on their other analyzer.The initial na result from the analyzer was 156 mmol/l.The repeat result from the other analyzer was 145 mmol/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
The na electrode lot number is r3503.The field service engineer (fse) inspected the analyzer and determined the event was caused by a defective na electrode.He then replaced the electrodes, primed the system, and performed an ion-selective electrode (ise) check with successful results.Calibrations qc and precision tests were performed with successful results.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2024; calibration alarms were noted.The investigation reviewed the qc recovery; the recoveries were within the specified range.There was no indication of a performance issue with the reagent.The investigation reviewed the alarm trace; multiple alarms were noted including"sample foam detection" which indicates possible poor sample quality.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• 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: 18776653
• Report Number: 1823260-2024-00540
• Device Sequence Number: 14538778
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/25/2024

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: 02/05/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/25/2024
• 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