MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS ISE MODULE (DOUBLE); CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964075001
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results for qc and patient samples from the cobas 8000 cobas ise module.Sample 1 initial sodium result was 127 mmol/l and the repeat result was 138 mmol/l.Sample 2 initial sodium result was 125 mmol/l and the repeat result was 136 mmol/l.The initial chloride result was 125 mmol/l and the repeat result was 97 mmol/l.The repeat results were believed correct.
Additional Manufacturer Narrative
The sodium electrode lot number was s10 and the chloride electrode lot number was p15.The expiration dates were not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d4 catalog no and primary udi number were updated.The field service engineer found there was an aging reference electrode and the dilution vessel contained residue.He cleaned the dilution vessel and replaced the reference electrode.He performed ise checks, calibration, and qc that passed.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 8000 COBAS ISE MODULE (DOUBLE)
• 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 46250-0457
• MDR Report Key: 19174514
• Report Number: 1823260-2024-01259
• Device Sequence Number: 12726724
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 05/17/2024

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: 05964075001
• Device Lot Number: 16L2-02
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/17/2024
• 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