MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100; AUTOMATED PREANALYTICAL SYSTEM

Model Number 8100

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer alleged an issue with 3 aliquot samples generated from the cobas 8100 system from 3 different primary samples.The customer thinks a patient sample mismatch occurred.The aliquot samples were run on a cobas 8000 system connected to the cobas 8100 system.All 3 aliquot samples were from rack 80926.The aliquot sample in position 1 produced a sample alarm for glucose (glu).The aliquot sample in position 2 produced sodium (na) results of 205.0 (unit of measure not provided) and 206.2, magnesium (mg2) results of 0.00 (unit of measure not provided) and 0.00, and calcium (ca2) results of (-) 0.10 (unit of measure not provided) and (-) 0.11.All of these results were accompanied by data flags invalidating the results.These results were not reported outside of the laboratory because the customer knew they were incorrect.The aliquot samples in positions 1 and 2 were a different color than their respective primary sample color.The aliquot samples appeared to have more hemolysis than the samples in the primary tubes.The aliquot sample in position 3 was empty.There was no allegation that an adverse event occurred.At the time these samples were processed by the aliquot module of the 8100 system, a single holder transportation error occurred.Upon rerunning the primary sample tubes following the error, the correct results were received for all 3 affected samples.The customer pulled approximately 20 patient samples that had been run either before the transportation error occurred or after the transportation error occurred.The customer did have to correct results for an unspecified number of samples for calcium, creatinine, alp, bilrubin, gt and crp that had been released from the laboratory.There was no allegation that any patients were adversely affected.The field service engineer (fse) visited the customer site and did not identify anything that might have caused the transportation error alarm.According to the information available, the primary samples were correctly pipetted.The transportation error occurred after the primary samples were correctly pipetted; therefore it is not believed that the possible sample mismatch was due to the error message.The investigation did however confirm a difference in the hemolysis, lipemia and icterus results between the primary sample and aliquot samples.Investigations are ongoing.

Manufacturer Narrative

During the investigation, the manufacturer was able to reproduce the issue.The customer was provided a workaround while investigations continue.

Manufacturer Narrative

The customer stated the issue occurred again for 3 new aliquot samples run on (b)(6) 2017 where the results were questioned.The results provided were not erroneous, however, the customer is alleging the system is aliquotting samples incorrectly.Patient 1 had an initial glucose result from the original tube of 7.33 (unit of measure not provided).The result from the aliquot was 6.76.Patient 2 had an initial glucose result from the original tube of 6.14.The result from the aliquot was 6.45.Patient 3 had an initial probnp result from the original tube of 2498 (unit of measure not provided).The result from the aliquot was 389.7.

Manufacturer Narrative

Investigations determined the issue occurs when the barcode labels of the aliquot tubes get stuck on the tube fixing mechanism.The customer was provided a workaround while additional functionality is added to the device to prevent this from occurring.

• Brand Name: COBAS 8100
• 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: 7071334
• MDR Text Key: 94223170
• Report Number: 1823260-2017-02791
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/16/2018

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: 07486740001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/08/2017; 11/08/2017; 11/08/2017
• Supplement Dates FDA Received: 12/08/2017; 12/27/2017; 01/16/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1