MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 ISE 1800 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 05964075001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2024

Event Type  malfunction  

Event Description

The initial reporter received questionable ise indirect na and k for gen.2 results from one patient sample tested on the cobas 8000 cobas ise module (double).The initial results were not reported outside of the laboratory as they did not relate to the patient's history.The initial na result from the module was 98.7 mmol/l.The first repeat result from another cobas 8000 module was 137.1 mmol/l.The second repeat result from the module was 136.5 mmol/l.The initial k result from the module was 2.90 mmol/l.The first repeat result from another cobas 8000 module was 3.94 mmol/l.The second repeat result from the module was 3.90 mmol/l.

Manufacturer Narrative

The na and k electrode lot numbers and the expiration dates were requested but not provided.The investigation is ongoing.

• Brand Name: COBAS 8000 ISE 1800 MODULE
• Type of Device: 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: 18856421
• MDR Text Key: 337426593
• Report Number: 1823260-2024-00691
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05964075001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1