MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 FLUID PACK; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Catalog Number 05122287001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

The customer reported that the quality controls for partial pressure of oxygen (po2) were running consistently below the mean.When running patient samples, it was determined that the analyzer was generating lower po2 patient results when compared to another cobas b 123 analyzer.Data was provided for a total of three patient samples.Upon evaluation it was determined that the questioned po2 results were flagged, alerting the user there was a problem with the results.However, it was determined that two of the patient samples had erroneous base excess of blood (be) and bicarbonate concentration in plasma (chco3) results.It was asked, but it is not known if any erroneous results were reported to parties outside of the laboratory.The first patient sample had an initial be result of 6.24 mmol/l.The same sample was repeated on the same analyzer, resulting as 5.50 mmol/l.It was stated that the results obtained on this analyzer were not consistent with the symptoms and diagnostics of the patient in question.The same sample was tested on a different cobas b 123 analyzer and resulted as 4.6 mmol/l.The results from the different cobas b 123 analyzer were stated to be consistent with the patient's symptoms.The second patient sample, from a female born on (b)(6) 1949, had initial results of 9.31 mmol/l for be and 34.9 mmol/l for chco3 on (b)(6) 2015.The sample was repeated on a cobas b 221 analyzer, resulting as 6.2 mmol/l for be and 31.6 mmol/l for chco3 on (b)(6) 2015.It was asked, but it is not known if the initial and repeat results were from the same sample or if each was measured from a different sample collection.The patients were not adversely affected.From (b)(6) 2014 to (b)(6) 2015, sensor cartridge lot 21543081 with an expiration date of january 2015 was used.From (b)(6) 2015, sensor cartridge lot 21543782 with an expiration date of march 2015 was used.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Investigation of the instrument data logs confirms the mentioned issue regarding the po2 control recovery and patient sample measurements.Control measurements were very low for one level of control at 4 different sensors.This behavior speaks to an erroneous sensor offset.This sensor offset can be traced to two lots of calibration pouches within the used fluid packs.One of these calibration pouch lots was present within 2 different fluid pack lots used on the system.The first affected fluid pack lot number in use on the system was lot number 21446153 and the second fluid pack lot number in use on the system was lot number 21446183.

Manufacturer Narrative

The comparison analyzer mentioned in the initial report was determined to be a cobas b221 analyzer and not a cobas b123 analyzer.

• Brand Name: COBAS B 123 FLUID PACK
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4449992
• MDR Text Key: 5394965
• Report Number: 1823260-2015-00599
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05122287001
• Device Lot Number: 21446153
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 01/06/2015
• 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
• Treatment: FRUZAMIDE (PATIENT 1); PROPAFALOL INFUSION (PATIENT 2); AUGMENTIN (PATIENT 1); VIVIOPTOL (PATIENT 1); ATROVENT (PATIENT 1); TAZOCIN (PATIENT 2); MAXALEN (PATIENT 1); ATORVASTATIN (PATIENT 2); THIAMINE (PATIENT 1); ACTROPID INSULIN (PATIENT 1); ASPARIN (PATIENT 2); HARTMANS SOLUTION (PATIENT 1); MIRIPENIM (PATIENT 1); CLOPIDOGREL (PATIENT 2); HYDROCORTISONE (PATIENT 1); WARFARIN (PATIENT 1); HALF STRENGTH SALINE (PATIENT 2); METOPRALOL (PATIENT 2); FRUSEMIDE (PATIENT 2); COMBIVENT NEBULISER (PATIENT 2); PANTOPRAZOLE (PATIENT 1); LIBRIUM (PATIENT 1); LACTALOSE (PATIENT 1); LEXAPRO (PATIENT 1)
• Patient Age: 065 YR