MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS IT 1000 CORE LICENSE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINCAL USE

Catalog Number 04420306001

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/16/2014

Event Type  malfunction  

Event Description

The customer experienced an issue with the transmission of results from the radiometer abl80 instrument to the laboratory information system (lis) through the cobas it1000.The results for the previously tested patient sample were sent along with the results for the patient sample currently being tested as a "double message" when the second sample was completed.This led to "missing results" in the cobas it 1000 and lis for (b)(6)patient samples.For example: sample a results in this "double message" were sent along with sample (b)(6) results.Sample (b)(6) was the only one recognized by the instrument driver and therefore only sample a results get sent to the cobas it 1000 application.This results in sample (b)(6) results not being logged in the cobas it 1000 or in the lis, thus the results are missing for sample (b)(6).The dates of occurrence were (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014 and (b)(6) 2014.The results for all samples were available on the screen of the radiometer abl80 instrument.No adverse events were reported.The issue also led to the sample type being changed for (b)(6) samples after the original sample type had been sent correctly.For example, if sample (b)(6) and sample (b)(6) were different sample types (e.G.Sample (b)(6) is arterial and sample (b)(6) is venous), then when the results for sample a were resent to the cobas it 1000, the sample type of sample (b)(6) was changed from arterial to venous.On (b)(6) 2014 patient (b)(6): incorrect sample type was mixed venous.Correct sample type was venous.On (b)(6) 2014 patient (b)(6): incorrect sample type was mixed venous.Correct sample type was arterial.On (b)(6) 2014 patient (b)(6): incorrect sample type was venous.Correct sample type was arterial.On (b)(6) 2014 patient (b)(6): incorrect sample type was venous.Correct sample type was arterial.On (b)(6) 2014 patient (b)(6): incorrect sample type was venous.Correct sample type was arterial.Both the correct and incorrect sample types were reported.No adverse events were reported.During further investigation, the issue could not be reproduced using a new database.

Manufacturer Narrative

Investigation determined this scenario only occurs with the combination of the cobas it1000 and the abl 80 flex analyzer.The cobas it 1000 is not connected to any abl 80 flex analyzers in the united states.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: COBAS IT 1000 CORE LICENSE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINCAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3693594
• MDR Text Key: 4293848
• Report Number: 1823260-2014-02019
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2014

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: Nurse
• Device Catalogue Number: 04420306001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 03/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2014
• 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