MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER

Catalog Number 05122287001

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/22/2014

Event Type  malfunction  

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The field service representative performed additional comparisons on both instruments with the same syringe.These measurements showed only moderate differences between the results.It was determined the instrument performed as expected.A pre-analytic issue was possible as the po2 value can increase within a couple of minutes and rolling of the syringe between the hands of the operator can improve the oxygen transfer within the sample and form foam.

Event Description

The customer discovered questionable po2 results when the results were compared to cobas b123 analyzer serial number (b)(4).The samples were collected from patients after a breath therapy.Data was provided for three patient samples.Refer to the attachment to the medwatch for all data.Information concerning which results were reported outside the lab was requested, but it was unknown.There was no death, injury, or admission to a medical facility.The lot number for the cobas b123 sensor cartridge was 21543281.The expiration date was requested, but was not provided.

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

• Brand Name: COBAS B 123 <4> 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: 4255168
• MDR Text Key: 12978293
• Report Number: 1823260-2014-08952
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111188
• 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: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 10/23/2014
• 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