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 07/26/2014

Event Type  malfunction  

Manufacturer Narrative

The laboratory method used for comparison was the siemens exl clinical chemistry analyzer.

Manufacturer Narrative

A specific root cause could not be determined.Additional information for investigation was requested, but not provided.No system related issues were found.A sample related issue is assumed to be the cause of the event.The sample measurement showed an extremely high thb and mchc values, which is indicative of the presence of micro-clots in the sample.Micro-clots can lead to a decrease or scattering of transmitted light during measurement, in turn, leading to an increased thb, however this could not be confirmed.

Event Description

The customer reported that they had been getting false positive bilirubin results from an unknown number of neonatal patient samples when compared to the laboratory method.The customer provided result data from 2 different patients.For these 2 patients, it was determined that erroneous results were reported for partial pressure of carbon dioxide at patient's temperature (pco2t), partial pressure of oxygen at patient's temperature (po2t), bicarbonate concentration in plasma (chco3-), base excess of blood (be), oxygen saturation (so2), bilirubin (bili), ion selective electrode (ise)potassium (k+), ise sodium (na+), ionized calcium (ca2+), glucose (glu), and lactate (lac).It was asked, but it is not known if same samples or different samples were used for repeat testing.All results from the analyzer were sent to the electronic health record of the affected patients and were given to the doctor.The results from the analyzer were not believed by the customer and only the results obtained using the laboratory method were used to assess if therapy was necessary.For patient one, eleven sets of replicate results from the analyzer were provided and can be seen on the attached sheet.Additional bilirubin results of 5.0 mg/dl for the analyzer method and 6.20 mg/dl for the laboratory method were provided from (b)(6) 2014.Additional bilirubin results of 13.7 mg/dl for the analyzer method and 12.10 mg/dl for the laboratory method were provided from (b)(6) 2014.Additional bilirubin results of 18.5 mg/dl for the analyzer method and 11.80 mg/dl for the laboratory method were provided from (b)(6) 2014.Additional bilirubin results of 12.6 mg/dl for the analyzer method and 14.93 mg/dl for the laboratory method were provided from (b)(6) 2014.It was asked, but it is unknown if these additional analyzer results were duplicates of any information on the attachment.Patient one also had bilirubin results of 5.70 mg/dl on (b)(6) 2014, 10.80 mg/dl on (b)(6) 2014, 16.30 mg/dl on (b)(6) 2014, 14.20 mg/dl on (b)(6) 2014, and 14.20 mg/dl on (b)(6) 2014 using the laboratory method.Patient two had a result of 20.5 mg/dl for bilirubin on the analyzer and a result of 16.7 mg/dl for bilirubin using the laboratory method.The patients were not adversely affected.Reagent and electrode lot numbers and expiration dates for the involved tests were asked for, but not provided.

Manufacturer Narrative

This event occurred in (b)(6).

• 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: 4059907
• MDR Text Key: 12604961
• Report Number: 1823260-2014-06785
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• 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
• Treatment: AMPICILLIN 3 TIMES DAILY (PATIENT ONE); NYSTATIN 3 TIMES DAILY (PATIENT ONE); CEFOTAXIM 3 TIMES DAILY (PATIENT ONE)
• Patient Age: 001 DA
• Patient Weight: 3