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

Model Number 8100

Device Problem Low Test Results (2458)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined that there were empty primary tubes on the e 801 analyzer coming from the cobas 8100.There was a bad sensor on the cobas 8100 which caused aliquot errors.The sensor was replaced and the system was verified to be working correctly.The instrument check passed.All customer calibration and controls were within specifications.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys tsh assay ver.2 on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.The samples were initially processed on a cobas 8100 pre-analytics system.The first sample initially resulted in a tsh value of 0.0344 uiu/ml.The customer decided to repeat the sample since a result from another test of the sample had a sample short flag on a different system on the same line.The sample was repeated, resulting in a value of 3.44 uiu/ml.The second sample initially resulted in a tsh value of 0.0233 uiu/ml on (b)(6) 2022 and repeated as 2.00 uiu/ml on (b)(6) 2022.The tsh reagent lot number used to measure the first sample was 57176501, with an expiration date of 31-jan-2023.The tsh reagent lot number used to measure the second sample was 597303.The reagent expiration date was requested, but not provided.

Manufacturer Narrative

The cobas 8100 is working as expected.The investigation could not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The issue was determined to be caused by low sample volume.It was observed that secondary tubes were almost empty.The root cause of the low sample volume could not be determined.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14210056
• MDR Text Key: 299288731
• Report Number: 1823260-2022-01196
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 07/08/2022

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 Model Number: 8100
• Device Catalogue Number: 07439920001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 05/06/2022; 06/15/2022
• Supplement Dates FDA Received: 05/31/2022; 07/08/2022
• 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