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

Catalog Number	08464537001
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	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na, k, and cl electrode lot numbers and expiration dates were requested, but not provided.The customer tried changing the ise reagents, but the issue still occurred.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested on the cobas pro ise analytical unit.The customer provided data for five patient samples with discrepant ise results.Results from the following assays were affected: na electrode, k electrode, cl electrode.The customer stated they changed the electrodes early in the morning.Calibration and controls passed.Later in the morning, the customer started noticing high na results for patient samples.The customer tried re-calibrating, but calibration was not successful.The customer tried using patient serum to activate the electrodes, but calibration was still failing.The customer then repeated patient samples on a second analyzer.Initial test results: patient sample 1: na = 127 mmol/l, k = 3.6 mmol/l patient sample 2: na = 127 mmol/l patient sample 3: na = 127 mmol/l patient sample 4: na = 129 mmol/l patient sample 5: na = 125 mmol/l, cl = 94 mmol/l repeat results: patient sample 1: na = 140 mmol/l, k = 4.03 mmol/l patient sample 2: na = 139 mmol/l patient sample 3: na = 139 mmol/l patient sample 4: na = 141.4 mmol/l patient sample 5: na = 141.7 mmol/l, cl = 105.9 mmol/l the repeat values were deemed correct.
Additional Manufacturer Narrative
Calibration and controls were acceptable.There was no indication of a reagent performance issue.The customer replaced a system reagent.An ise check, calibration, controls, and precision studies were successful.Precision was within specifications.The investigation determined the customer's 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: 18587685
• Report Number: 1823260-2024-00233
• Device Sequence Number: 7030788
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 02/14/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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