MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 4 ROCHE OMNI S4 SYSTEM; BLOOD GAS ANALYZER

Catalog Number 03337138001

Device Problem False Device Output (1226)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

The customer reported that when in routine operation, a sample barcode was incorrectly identified by scanning the barcode with the barcode reader from the analyzer.The date of the event was not clear.A clarification has been requested.When scanning a barcode with the identification number "(b)(4)", an incorrect identification number of "(b)(4)" was reflected on the result printout from the analyzer.When re-scanning the barcode, the correct number of "(b)(4)" was then reflected on the result printout from the analyzer.It was asked, but it is not known if any erroneous results were released from the laboratory.No patients were adversely affected due to the event.According to the customer, their barcode has a check digit format.The customer also stated that the original barcode scanner that came with the instrument was not used.A locally sourced barcode scanner was used with the instrument.

Manufacturer Narrative

The date received by the manufacturer was confirmed to be 07/28/2015.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

The date the event occurred was confirmed as (b)(6) 2015.

Manufacturer Narrative

It was determined that the customer was using a bacode scanner which is not supported by roche.The affected patient barcode was provided for investigation.During investigations, the barcode was scanned on a retention instrument using a roche supported barcode scanner.The correct patient id was entered when the barcode was scanned on the retention instrument.A specific root cause for the issue could not be identified.

• Brand Name: COBAS B 221 4 ROCHE OMNI S4 SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4949898
• MDR Text Key: 6634423
• Report Number: 1823260-2015-03880
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K032311
• 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: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 03337138001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/01/2015
• 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
• Patient Age: 069 YR