MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer alleged erroneous results for 1 patient tested for d bili direct bilirubin (d bili) on a cobas 6000 c (501) module.One patient sample was being tested for multiple chemistry tests and total psa.The total psa test was processed first and then the sample was sent to the c501 module for the other tests.When the tests were completed and were sent to the host, the tech noticed that the d bili result in the laboratory information system (lis) was 5.22 mg/dl.The tech did not accept this result and reviewed what the c501 module tested originally.The initial d bili result was 0.20 mg/dl with a data flag and the sample repeated with the same result.The result of 0.20 mg/dl with a data flag was believed to be the correct result and was reported outside of the laboratory.The result of 5.22 mg/dl could not be located in the data review screen but, according to the log from the lis, this result was produced by the c501 module.Attempts were made to determine when this result was produced, however, due to the customer¿s settings, this could not be confirmed.The result of 5.22 mg/dl could have been overwritten by the next result for d bili.Another potential explanation for the 5.22 mg/dl result was that the customer used an unspun whole blood sample that was tested for d bili, however, the customer states this did not occur.No adverse event occurred.The d bili reagent lot number was 21901301 with an expiration date of 09/30/2018.

Manufacturer Narrative

A specific root cause was not identified.It is unclear if the result of 5.22 mg/dl was overwritten by the next result for d bili or if the customer placed an unspun whole blood sample with the same sample id in a serum rack by accident.The customer stated they are not having any further issues.

• Brand Name: COBAS 6000 C501 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 6799905
• MDR Text Key: 83255590
• Report Number: 1823260-2017-01719
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 09/13/2017
• 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
• Patient Age: 53 YR
• Patient Weight: 57