MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY LAB CORE LICENSE 3.X; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Catalog Number 09180443001

Device Problems Application Program Problem (2880); Insufficient Information (3190)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

The initial reporter stated they had an issue with mismatched data for one patient sample on the cobas infinity system.The barcode label id for a sample tested on a cobas 8000 c (701) module on (b)(6) 2022 (sample a) was reused for a different patient sample (sample b) on (b)(6) 2022.The new order for sample b had new patient demographics but triggered the transmission of results from sample a to the customer's host system for this new sample b.Results from the previous patient (with sample a) were transmitted for sample b and caused by the reuse of an existing barcode, the validation process of infinity, and the configuration of the action codes within infinity.The customer noticed the issue while validating patient results in their host system.The results were then rejected in the customer's host system.The customer expects the cobas infinity system to work properly when barcodes are reused within 7 days.

Manufacturer Narrative

The action codes in the cobas infinity system were modified to reject samples with no or different patient demographics.During investigations, it was determined that the order for the sample id was not closed by the end of day process on (b)(6) 2022.The customer stated that the system was rebooted on (b)(6) 2022 and the database was restored as orders from all samples were closed the previous day and deleted during the overnight cleanup process.Per product labeling of cobas infinity: "tube ids can only be reused once the maximum time period configured in the automatic order closing parameter is exceeded, otherwise patient information and results could become confused." during investigations, it was determined that the maximum time period configured in the cobas infinity was exceeded and the order for sample a should have been closed.The investigation is ongoing.

Manufacturer Narrative

Investigations have determined that due to off-label use of the software, two tubes with the same id were co-existing in the laboratory within the same day, and information regarding both of them was received in cobas infinity.A software issue has also been identified as the cobas infinity is not restarting nor resuming the end-of-day process after being interrupted as it was in this event.There is also no documentation available in the service or user manual, regarding how cobas infinity should behave in case the end-of-day process is interrupted.

Manufacturer Narrative

New details of the event have been provided.The customer uses short 6-digit tube identifiers/barcodes.The first 3 digits are used to distinguish senders who send in their tubes to the lab.That means only 3 digits are used to identify tubes from the same sender.When there are only 999 different tube ids per sender, tube ids necessarily have to be reused after some time.The laboratory stated that tube ids would not be reused within a 7 day timeframe, but tubes with existing tube ids have been found to arrive in the laboratory earlier than this timeframe.Before the event, the order actions in infinity were adapted to reject order messages with existing order ids if the patients do not match.The customer does not send patient ids, which means only patient demographics can be used.It is not known if an order message is an add-on for an existing order that includes a change of patient demographics or if the order is a new order with a new patient.Order actions in infinity can only distinguish if a patient with the same demographics already exists in other orders, which is easily possible because orders for the same patients can be created multiple times.The incident occurred in the following order: 1.Some time before (b)(6) 2022, the original order was sent to infinity with tube id 487584 and patient a 2.The tube was analyzed and results were sent to the customer's laboratory information system (lis) 3.On (b)(6) 2022, a new order was sent to infinity with tube id 487584 and patient b.4.On (b)(6) 2022, an add-on was ordered for id 487584 and patient a.5.The analyzer which measured the samples saw both tubes on (b)(6) 2022.6.Infinity resent old results of patient a to the lis because the new order was likely interpreted as an add-on order message that includes a patient demographics change.Demographics changes trigger de-validation of results, then new auto validation and resend to the lis.7.The customer noticed the issue when validating results in the lis as they can see that there are two tubes in the system with the same id.They noticed the issue and rejected the results so that no mix-up data was sent to medical staff.After the incident occurred, the following happened: 1.General parameters in cobas infinity were adjusted to close orders and delete them after 1 day.2.The end of day process was triggered manually to close all orders of the day.3.On (b)(6) 2022, orders were deleted automatically by end of day process.4.The customer then found that 300 add-on tests/retrievals from the c 701 analyzer could not be performed.5.The backup from (b)(6) 2022 was used to restore the deleted orders so that add-ons and retrievals worked again.6.The rule engine in infinity was manually triggered to re-open orders for all tubes ("open all").7.A work around in the customer's workflow was implemented to sort out tubes that were capped and had already been seen in the analyzers used for sample measurement.

• Brand Name: COBAS INFINITY LAB CORE LICENSE 3.X
• Type of Device: CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13522448
• MDR Text Key: 292192163
• Report Number: 1823260-2022-00358
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2022

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 Catalogue Number: 09180443001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 02/11/2022; 03/10/2022
• Supplement Dates FDA Received: 03/08/2022; 03/28/2022
• 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