MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 CORE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 04745868001

Device Problem False Device Output (1226)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that the cobas 6000 core unit was using an erroneous unit of measure.The customer stated that they had been using a reporting unit of nmol/l for the cortisol assay on the e601 analyzer, which is connected to the cobas 6000 core unit.Starting on (b)(6) 2015, the quality control data from the analyzer could not be uploaded to the customer's quality control software.Since controls were normal, they continued to run the analyzer.After troubleshooting with a support person from the control software company, it was determined that the analyzer reporting unit had been changed to g/dl.The control software, which is set to use units of nmol/l, could not recognize the data from the analyzer due to this change.When viewing patient and quality control results from the data review screen in the analyzer software, the results from (b)(6) 2015 were shown in units of nmol/l.When a printed report of these results were ordered from the analyzer, the printed results showed units of g/dl.When viewing result in the individual quality control run status screen in the analyzer software, the reporting unit for results is displayed as g/dl, but the value is the same as what is shown in the data review screen.A lot calibration generated on (b)(6) 2015 showed reporting units of g/dl, but when compared to the last calibration report which used nmol/l, the standard target values are the same.The utility application screen of the analyzer software showed the selected unit for the cortisol assay as g/dl.This screen showed that there was an option of selecting only units of g/dl, ug/l, or ug/dl.The customer stated that the last data generated before (b)(6) 2015 was on (b)(6) 2015 and all control and patient reports from this date were in nmol/l units.Due to the issue, the customer was concerned that erroneous results may have been generated from (b)(6) 2015 onward.When comparing quality control data from prior to (b)(6) 2015, the values did not show any great changes.This suggested that the analyzer did not actually perform calculation of the values in g/dl.It was believed that only the reporting unit was changed and not the calculation of the value.It was also determined that the unit of g/dl is not an available unit of measure according to labeling.When checking the reporting units available for selection on another cobas 6000 analyzer, only options for nmol/l, ug/l, and ug/dl could be seen.The customer checked all other assays on the problem analyzer.All application values and settings are the same as manufacturer settings and match between this analyzer and the other analyzer.The clinician was informed of the issue.The customer has confirmed that no one has changed the unit on the analyzer in question.The customer stated that 24 patient samples were involved in the issue.Data was provided for a total of 22 patient samples.It was asked, but it is not known if any erroneous values were reported outside of the laboratory for these samples.The first sample resulted as 1107 g/dl.The second sample resulted as 688.0 g/dl.The third sample resulted as 567.1 g/dl.The fourth sample resulted as 616.1 g/dl.The fifth sample resulted as 1310 g/dl.The sixth sample resulted as 1750 g/dl accompanied by a data flag.The seventh sample resulted as 1750 g/dl accompanied by a data flag.The eighth sample resulted as 1035 g/dl on (b)(6) 2015.The sample was also repeated on (b)(6) 2015, resulting as 1035 g/dl.The ninth sample resulted as 497.2 g/dl on (b)(6) 2015.The tenth sample resulted as 302.8 g/dl on (b)(6) 2015.The eleventh sample resulted as 1750 g/dl on (b)(6) 2015 accompanied by a data flag.The twelfth sample resulted as 558.0 g/dl on (b)(6) 2015.The thirteenth sample resulted as 488.1 g/dl on (b)(6) 2015.The fourteenth sample resulted as 942.1 g/dl on (b)(6) 2015.The fifteenth sample resulted as 656.5 g/dl on (b)(6) 2015.The sixteenth sample resulted as 800.3 g/dl on (b)(6) 2015.The seventeenth sample resulted as 660.8 g/dl on (b)(6) 2015.The eighteenth sample resulted as 436.3 g/dl on (b)(6) 2015.The nineteenth sample resulted as 324.4 g/dl on (b)(6) 2015.The twentieth sample resulted as 1720 g/dl on (b)(6) 2015.The twenty-first sample resulted as 275.0 g/dl on (b)(6) 2015.The twenty-second sample resulted as 849.0 g/dl on (b)(6) 2015.The patients were not adversely affected.The cortisol application was deleted from the analyzer and then re- downloaded.After doing this, it was found that only units of nmol/l, ug/dl, and ug/l were available as options.Preliminary investigations have determined that the issue may have been caused by a faulty "cf card".

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.It is believed that the issue was due to an error on the cf card which was in use on the analyzer.

• Brand Name: COBAS 6000 CORE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5097523
• MDR Text Key: 26564170
• Report Number: 1823260-2015-04208
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04745868001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 09/10/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1