MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100 MODEL BETA WITH CRW; AUTOMATED PREANALYTICAL SYSTEM

Catalog Number 09237208001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 08/17/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable gen.2 ise indirect for na results for 1 patient sample on a cobas pro module.The customer was prompted to repeat the sample as they noticed that samples were coming off of the analyzer uncentrifuged.The initial na result was 133 mmol/l.The repeat result was 139 mmol/l.The repeat result was deemed correct.

Manufacturer Narrative

The na electrode lot number and expiration date were not provided.The qc recovery data provided was acceptable.It was found that affected samples were loaded onto a spin tray in the analyzer that did not centrifuge the samples before loading onto the instrument.The investigation is ongoing.

Manufacturer Narrative

The root cause of the event was found to be that the customer accidentally loaded a no spin tray that gave sample check errors and then reloaded the samples into a spin tray that did not did not centrifuge the samples as they had already been previously loaded onto the analyzer.No product problem was identified.

• Brand Name: COBAS 8100 MODEL BETA WITH CRW
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• 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: 17756855
• MDR Text Key: 323733879
• Report Number: 1823260-2023-02986
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 11/21/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 09237208001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/21/2023
• 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
• Patient Sex: Male