MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 05641489001

Device Problem Low Test Results (2458)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

E1 facility name - the full facility name was provided as (b)(6).The reagent lot number and the expiration date were requested but not provided.The field service engineer (fse) inspected the module and found that the gear pump pressure was low and adjusted it.The fse checked the rinse mechanism for cuvettes and cleaned all nozzles.Instrument checks were performed and found to be acceptable.After service, no further issues were reported by the customer.The investigation determined that the issue is consistent with insufficient service maintenance and the service actions resolved the issue.

Event Description

There was an allegation of questionable calcium assay results for 3 patient samples on a cobas 8000 cobas c 701 module.The customer noticed a "non-sensitive index" alarm around the same time they received the initial low results.Patient 01: the initial result was 1.510 mmol/l, and the repeat result was 2.060 mmol/l.Patient 02: the initial result was 1.410 mmol/l, and the repeat result was 2.010 mmol/l.Patient 03: the initial result was 1.660 mmol/l, and the repeat result was 2.170 mmol/l.

• Brand Name: COBAS 8000 C 701 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: 18950899
• MDR Text Key: 338445465
• Report Number: 1823260-2024-00852
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05641489001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• 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