MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 121; BLOOD GAS ANALYZER

Catalog Number 03143562001

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/16/2014

Event Type  malfunction  

Event Description

The customer experienced an issue with the results for qc material overwriting the results for patient samples in the laboratory information system (lis).Of the data provided for two patient samples, the following results were discrepant.Patient 1: po2 result was 88.5 mmhg.The level 1 qc result that overwrote the patient result was 58.6 mmhg.Pco2 result was 35.1 mmhg.The level 1 qc result that overwrote the patient result was 62.2 mmhg.The level 2 qc result that overwrote the patient result was 44.6 mmhg.Ph result was 7.427.The level 1 qc result that overwrote the patient result was 7.197.Sodium result was 139.7 mmol/l.The level 1 qc result that overwrote the patient result was 122.3 mmol/l.Chloride result was 103.2 mmol/l.The level 1 qc result that overwrote the patient result was 88.4 mmol/l.Ionized calcium result was 4.95 mg/dl.The level 1 qc result that overwrote the patient result was 6.09 mg/dl.The level 2 qc result that overwrote the patient result was 4.71 mg/dl.Potassium result was 3.84 mmol/l.The level 2 qc result that overwrote the patient result was 4.76 mmol/l.Patient 2 tested on (b)(6) 2014: po2 result was 22.2 mmhg.The level 3 qc result that overwrote the patient result was 144.0 mmhg.Pco2 result was 57.1 mmhg.The level 3 qc result that overwrote the patient result was 24.6 mmhg.Ph result was 7.243.The level 3 qc result that overwrote the patient result was 7.554.Sodium result was 130.6 mmol/l.The level 3 qc result that overwrote the patient result was 154.4 mmol/l.Chloride result was 99.8 mmol/l.The level 3 qc result that overwrote the patient result was 121.2 mmol/l.Ionized calcium result was 5.23 mg/dl.The level 3 qc result that overwrote the patient result was 2.26 mg/dl.Potassium result was 3.80 mmol/l.The level 3 qc result that overwrote the patient result was 7.0 mmol/l.Information concerning if any erroneous results were reported outside the laboratory was requested but was not provided.Information concerning if any patients were adversely affected was requested but was not provided.Information concerning the lot numbers and expiration dates for the assays involved was requested but was not provided.

Manufacturer Narrative

This event occurred in (b)(6).While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Manufacturer Narrative

The investigation alternately tested samples and qc material to verify that the cobas b121 instrument sent all results through the astm protocol to an astm simulator correctly.No issues were found and all results were sent to the astm simulator correctly.Based on the investigation, it was determined the astm protocol was working according to specifications.It was assumed that the root cause was with the lis/his systems.

• Brand Name: COBAS B 121
• 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: 3938406
• MDR Text Key: 4597826
• Report Number: 1823260-2014-05278
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K111188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03143562001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 06/18/2014
• 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