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	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The k electrode lot number and expiration date were not provided.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ise results for 1 patient's plasma sample tested on a cobas pro ise analytical unit.Results for the potassium (k) test were affected.Initial result: 5.96 mmol/l.The physician questioned the result and asked to rerun the sample.On 14-dec-2023 the sample was rerun and resulted in a value of 3.95 mmol/l.
Additional Manufacturer Narrative
B6 and concomitant medical product sections were updated.This is a correction where the patient was not taking kayaxelate when the initial result of 5.96 mmol/l was obtained.On (b)(6) 2023, the physician called the laboratory questioning the result stating that the patient had hypokalemia since (b)(6) 2023 and the kinetics did not stick with the drug substitution.On the same day, the sample from (b)(6) 2023 that resulted in 5.96 mmol/l was then repeated and the repeat result was 3.95 mmol/l.The investigation did not identify a product problem.The cause of the event was consistent with pre-analytical factors.

• 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: 18495286
• Report Number: 1823260-2024-00123
• Device Sequence Number: 14368720
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIFFUK 312 MG/CAPSULE (6 CAPSULES/DAY BY MOUTH); KAYEXALATE (SODIUM POLYSTYRENE SULFONATE)
• Patient Sex: Unknown