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

Catalog Number 05964075001

Device Problem Low Test Results (2458)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

The initial reporter stated they noticed low results for an unspecified number of patient samples tested with the na electrode on a cobas 8000 ise module.The patient results were abnormally low and they received delta check flags.The samples were repeated on a second analyzer and normal, trusted results were measured.The customer provided an example of one patient sample with discrepant na results.The sample initially resulted in a na value of 130 mmol/l.Due to receiving delta check flags on patient samples, the customer repeated the sample on a second analyzer.The repeat na result from the second analyzer was 137 mmol/l.The repeat value was deemed correct and a corrected report was issued.

Manufacturer Narrative

The serial number of the cobas 8000 ise module is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Quality controls were acceptable.There was no indication of a reagent performance issue.The field service engineer found that the mixer failed.The mixer was replaced and dispensing adjustments were performed.The bath level sensor and bath valves were also replaced.Ise checks, calibration, controls, and precision studies were performed; all results were within specifications.The investigation determined the service actions resolved the issue.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: COBAS 8000 COBAS ISE MODULE (DOUBLE)
• 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 46250-0457
• MDR Report Key: 19032556
• MDR Text Key: 339250092
• Report Number: 1823260-2024-01022
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05964075001
• Device Lot Number: U1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1