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 Consequences Or Impact To Patient (2199)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

The customer reported that they had an erroneous, but believable total hemoglobin (thb) result generated from the cobas b 123 instrument for one patient sample.The customer noted that there was a spurious thb result within the time span of 5:21 a.M.To 11:14 a.M.No blood transfusion had been given to this patient.The customer provided measurement data for a total of 5 different samples measured from the same patient.All samples were drawn from the patient's arterial line.Of the data provided, it was determined that there were erroneous results for thb, ion selective electrode (ise) potassium, hematocrit (hct), and glucose (glu).The erroneous results were generated from a cobas b 123 analyzer located on a ward and samples were run on the analyzer by a nurse.Each set of sample measurements are from a separate sample drawn at different times.A sample tested at 05:21 resulted as 23.7% accompanied by a data flag for hct, 4.02 mmol/l for ise potassium, 5.1 mmol/l for glu, and 71.5 g/l for thb.A sample tested at 9:55 resulted as 34.1% for hct, 4.42 mmol/l for ise potassium, 7.9 mmol/l accompanied by a data flag for glu, and 106.8 g/l for thb.The customer is questioning the thb result from the sample tested at 9:55.A sample tested at 11:14 resulted as 22.7% accompanied by a data flag for hct, 4.46 mmol/l for ise potassium, 7.9 mmol/l accompanied by a data flag for glu, and 70.7 g/l for thb.A sample tested at 13:25 resulted as 22.3% accompanied by a data flag for hct, 4.41 mmol/l for ise potassium, 8.2 mmol/l accompanied by a data flag for glu, and 71.3 g/l for thb.Another sample was tested on an abbott architect ci 8200 analyzer on (b)(6) 2014 and resulted as 4.3 mmol/l for potassium and 4.7 mmol/l for glucose.The same sample which was tested on the abbott architect was also tested on a horiba medical abx pentra df120 hematology analyzer on (b)(6) 2014, resulting as 77 g/l for hemoglobin.The results from the abbott architect and horiba pentra were only used for comparative purposes.The patient was not adversely affected.The reagent or electrode lots and expiration dates used for the hct, ise potassium, glu, and thb tests were asked for, but not provided.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be determined.The instrument data showed no indication of a quality issue.The qc-data are in normal range, no related errors were found and no signs of a calibration based problem could be found.Information provided for investigation strongly indicates pre-analytic issues, such as sedimentation effects, caused the alleged thb value.A sample/handling related error is assumed.

• 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: 4042119
• MDR Text Key: 4859254
• Report Number: 1823260-2014-06572
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 08/11/2014
• 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
• Patient Age: 064 YR