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

Catalog Number 07154003001

Device Problem High Test Results (2457)

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

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).Medwatch field phone number was provided as (b)(6).

Event Description

The customer stated that they received erroneous values for five patient samples tested for crep2 creatinine plus ver.2 (crea) on two cobas 8000 c (701) module - c701 analyzers.The values present in the cobas infinity core middleware system did not match the same values generated by the analyzers for the samples.No erroneous values were reported outside of the laboratory as the crea values in the infinity system were not consistent with values of other renal tests.Refer to the attachment for all patient data.Testing orders were assigned to a c701 analyzer (c701 - line 1), but due to a reagent shortage, no values were generated and reagent shortage messages were transmitted to the infinity system.The infinity then generated values higher than 200 umol/l for these same samples (infinity - line 1 result).The customer saw that the values in the infinity system were too high, so the customer checked the results in the software of the c701 - line 1 system.The customer did not find result values for these samples and the software indicated that there was a reagent shortage.Crea testing for the samples was then manually programmed to be repeated on a second c701 analyzer (c701 - line 2) and the samples resulted with values.Results generated with both c701 analyzers were merged into the customer's laboratory information system (lis).The c701 - line 2 repeat results were the values seen in the lis system.The results from the lis did not match with the infinity results.No adverse events were alleged to have occurred with the patients.The crea reagent lot number and expiration date were asked for, but not provided.

Manufacturer Narrative

Investigations of the provided data determined that all affected orders were created from an external host.Messages for creating the order contained a date of birth which was the same date as the order creation date.This means that the patient's age was considered as 0.Patient age is used to calculate the crea result.The results returned by the cobas infinity system are the same as experienced by the customer when the patient's age is 0.As the customer's host system is sending an incorrect date of birth, an unexpected result will occur when calculating the crea result.The customer confirmed that the patient's age was different in their host system than the age that was actually sent to the cobas infinity system.No software issues were found with the cobas infinity system.

Manufacturer Narrative

Medwatch field has been updated.

• 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: 7457409
• MDR Text Key: 107088134
• Report Number: 1823260-2018-01272
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1