MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 07154003001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The patient was born in (b)(6).The investigation is ongoing.

Event Description

The initial reporter complained of low results for an unknown number of aliquot patient samples tested for tnt g5 stat from a cobas 8100 pre-analytical system.The field service engineer (fse) adjusted the aliquot group volume from 200 u/l to 750 u/l.The customer ran 2 patient samples for troubleshooting purposes and the volume in the aliquot tube was less than 500 u/l.The customer programmed the control unit (cu) of the cobas 8100 to aliquot 800 ml but it was only dispensing 500 ml.The field application specialist (fas) found that the cobas infinity software was overriding the settings in the cu of the cobas 8100 system and was dispensing 500 ml.The customer provided the following example of discrepant results for 1 patient sample: the original result was 7.58 ng/l.A second sample was obtained and the result was 340.7 ng/l.This result prompted repeat testing with the original sample.The repeat result from the original sample was 308.9 ng/l.The low result was reported outside of the laboratory.The tnt g5 stat reagent lot number and expiration date were not provided.The cobas 8100 system serial number was (b)(4).

Manufacturer Narrative

The investigation found the customer entered an incorrect volume calculation into the cobas infinity software.The targets were changed and the volume calculation was updated from calculated volume to fixed volume 800.When a cobas 8100 instrument is connected to cobas infinity software, the instrument gets the aliquot volume from the cobas infinity software, so all changes on the control unit (cu) must also be configured in the cobas infinity software.The issue was solved with a configuration change.The customer had no further issues.The investigation did not identify a product problem.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11306521
• MDR Text Key: 232363545
• Report Number: 1823260-2021-00394
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: 07154003001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1