MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 SYSTEM; BLOOD GAS ANALYZER

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/29/2015

Event Type  malfunction  

Event Description

This report is for the cobas b 123 analyzer with serial number (b)(4).The customer reported that they received questionable results for an unspecified number of samples tested for ion selective (ise) sodium on cobas b 123 analyzer serial number (b)(4).The analyzer was moved from one site to another with all consumables on board on (b)(6) 2015.The analyzer was powered off for approximately one hour.After moving the analyzer, the sensor did not settle, so it was replaced with sensor lot 21545185.Multiple calibrations were also performed after the relocation.The instrument sat unused for a while and it was then used side by side with an il gem4000 analyzer for a few days.The customer then noticed a discrepancy of 10 mmol/l between the analyzers for one patient sample tested for ise sodium on (b)(6) 2015.This sample was checked on other cobas b 123 analyzers and a siemens blood gas analyzer as well; results on these analyzers were as expected.It was stated that discrepancies were noticed on some other patient samples since this first one, but not all samples are affected.The customer noted that one level of control was within range, but higher than the usual running mean.The customer provided data for a total of eleven patient samples tested for multiple tests.Of the data provided, ten samples had erroneous results for ise sodium (na +), lactate (lac), partial pressure of oxygen (po2), and calcium (ca2+).It was asked, but it is not known what units of measure were used for the lac, po2, and ca2+ tests.It was asked, but it is not known if any patient results were reported outside of the laboratory.The ten samples were tested on three different cobas b 123 analyzers; serial numbers (b)(4).The samples were also tested on a gem 4000 analyzer, architect analyzer, gem 3000 analyzer, and a radiometer abl 90 analyzer.This medwatch will refer to cobas b 123 analyzer serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for information related to cobas b 123 analyzer serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for information related to cobas b 123 analyzer serial number (b)(4).It was asked, but it is not known if any patients were adversely affected due to the event.No adverse events were alleged.The sensor lot and expiration dates were asked for, but not provided for cobas b 123 analyzer serial numbers (b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

No adverse events occurred for this event.No erroneous results were reported outside of the laboratory and all results were used for evaluation purposes only.The following units of measure are used; lac is mmol/l, po2 is kpa, and ca2+ is mmol/l.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.It was determined that either sensor lot 21545184 or 21545185 was in use during the event.The instrument log data and retention materials of sensor lots 21545184 and 21545185 were checked.Both sensor lots expired on 06/19/2015.Retention materials showed that na+ and ca2+ parameters were no longer within specifications 3 months after the expiration.It is not possible to determine if the sensor cartridges still met specifications at the time of expiration on 06/19/2015.Review of available customer instrument log data showed that the inaccurate na+ and ca2+ results were due to an inaccurate calibration value.This is caused by a signal drift.

• Brand Name: COBAS B 123 SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4805559
• MDR Text Key: 5830024
• Report Number: 1823260-2015-03544
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/30/2015
• 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