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

Model Number B221

Device Problem Improper Device Output (2953)

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

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they had a patient demographic mismatch for a patient sample tested on the cobas b 221<4>=roche omni s4 system (b221).Refer to the attachment for the affected patient result printouts.Correct results were printed for a first patient (right side of attachment), but the same set of results were reported on the printout for a second patient of different name and patient identifier (left side of attachment).The customer stated that they select patients in the system software by scanning the barcode label of the patient sample.The measurement database of the analyzer was checked, but only the results with the incorrect patient name and identifier (patient 2) could be seen.No adverse events were alleged to have occurred with any of the patients.

Manufacturer Narrative

Investigations determined that the analyzer is working within specifications.The instrument database shows that in the database, the measurement in question on (b)(6) 2017, 04:22 was stored with patient identifier (b)(6).The previous measurement at 04:05 was also associated with patient identifier (b)(6).The following scenario may have occurred: the measurement was completed on (b)(6) 2017 at 04:22.Initially, the correct information (patient identifier (b)(6)) was entered via barcode.The results were generated and the automatic printout started (with patient identifier (b)(6) as the first printout).In the meantime, the measurement workflow was still processing.If the input value screen still open at this time the user may have selected the "last patients" function at that time, thereby replacing the patient information with one of the previous measurements (patient identifier (b)(6)).At the end of the measurement, a transmission containing patient identifier (b)(6), as well as database entry with that patient identifier would have been created.A printout out of the database would contain patient identifier (b)(6) (second printout).An improvement was implemented with a new software version so that it is no longer possible to edit any patient information during the workflow as soon as the automatic printout has started.

Manufacturer Narrative

It has been clarified that the operator mistakenly scanned the barcode label of patient 2 when measuring the patient 1 sample.The results for patient 1 showed on the printout with the name for patient 2.The database contained only data with the name of patient 2, but the results of patient 1.The correct results for patient 2 were not found in the database.

• 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 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: 6807057
• MDR Text Key: 83750400
• Report Number: 1823260-2017-01770
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: B221
• Device Catalogue Number: 03337138001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1