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

Model Number C8100

Device Problem Misassembly by Users (3133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained that the cobas c8100 did not recognize the cap color on the sample tube for 1 patient.Purple top tubes are for hematology tests and green top tubes are for chemistry tests.The phlebotomist mistakenly put a complete blood count (cbc) label on a green top tube that was meant for chemistry.The green top tube was sent to a cismex xn 9000 hematology instrument where the platelet count was 143.This result was reported outside of the laboratory.The employee in the laboratory noticed the green top tube in the hematology department and realized this was the incorrect tube for this test.The doctor was called immediately and told that the result was incorrect.A sample in a purple top tube from the patient was sent to the hematology department at the same time as the green top tube.The platelet count from the purple tube was 256.This result was reported outside of the laboratory and considered to be correct.The patient was treated based on this result.There was no delay in patient treatment due to this issue.No adverse event occurred.The cobas c8100 should have moved the green top tube to the error tray after a cross check of the hematology label on the tube against the tube cap color was performed.It is possible that tube recognition was not enabled on the cobas c8100 for this sample type.It is not known whether the customer had this setting enabled.If the cross check fails, and the cobas c8100 cannot determine an appropriate route for the sample tube based on the cap color, the sample should go to the error tray.

Manufacturer Narrative

The field application specialist (fas) visited the customer site.The only sample type programmed in the cobas c8100 was whole blood (wb) and not cbc.The fas had to assign green and purple tubes to the wb sample type.The cobas 8100 does not differentiate between light green tubes and dark green tubes.Since the phlebotomist had mislabeled a light green tube with a cbc label, the tube was incorrectly sent to the cismex xn 9000 hematology instrument.The fas built a new sample type of wb/nahep for the dark green tubes.This way, wb would only be programmed for purple tubes and the green tubes would no longer be sent to the cismex xn 9000 hematology instrument due to correctly programmed tube recognition.The fas tested the new sample type and the green tube was rejected.

Manufacturer Narrative

On a follow up call to the customer, it was noted that the customer uses lithium heparin tubes and sodium heparin tubes.In the initial set up of the cobas c8100 instrument, lithium heparin tubes were defined as serum plasma and sodium heparin tubes and edta tubes were defined as whole blood.The customer made a different specimen type for sodium heparin tubes so it is no longer defined as whole blood.Since this change was made, the customer has not had any further issues.A specific root cause could not be identified for this event.Additional information was requested for investigation but was not provided.Based on the information available for investigation, no system malfunction was identified.

• 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: 6272570
• MDR Text Key: 65965236
• Report Number: 1823260-2017-00127
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

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: C8100
• Device Catalogue Number: 07439920001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/06/2017; 03/27/2017
• 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