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 09/13/2016

Event Type  malfunction  

Event Description

The customer complained of erroneous results for 1 neonate patient tested for bilirubin total gen.3 (bilt3).The erroneous result was reported outside of the laboratory.The initial bilt3 result was 24.6 mg/dl.This result was reported to the doctor.The doctor called back almost immediately and requested the sample be rerun.The sample was repeated twice with results of 15.7 mg/dl and 15.6 mg/dl.The repeat results were believed to be correct.No adverse event occurred.The bilt3 reagent lot number was 13902101 with an expiration date of 09/30/2017.The field service representative ran instrument mechanical and fluid checks and all were acceptable.Precision tests were acceptable.It was noted that quality controls (qc) with multiple lot numbers had been acceptable for the past month.A specific root cause could not be identified.Both instrument and reagent problems can be excluded since calibration and qc were acceptable and the instrument tests were within specification.The most likely root cause of the issue is a pre-analytical issue.It was suggested that the sample may not have been handled correctly.Based on the information provided for investigation, there may have been too much sample volume pipetted for the initial run or some material found its way into the measuring cuvette which caused the higher value.

• 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: 5972682
• MDR Text Key: 55453058
• Report Number: 1823260-2016-01449
• 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
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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
• Date Manufacturer Received: 09/13/2016
• 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: 6 DA