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

Catalog Number 04745914001

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

The customer noticed qc results were drifting and that they received questionable high triglyceride results for an unknown number of patient samples.The issue involved three cobas c501 analyzers at the site.Refer to the medwatches with patient identifiers (b)(6) for the other analyzers.Data was only provided for one sample as an example.The initial result was 250 mg/dl and the repeat result was 40 mg/dl.All of the erroneous results were reported outside the laboratory.The physicians called and thought the results were high.The lower repeat results were believed to be correct.The patients were not adversely affected.The reagent lot number was 61450901 with an expiration date of 05/31/2016.The field service representative could not find a cause.He ran precision testing which passed within specifications.He confirmed there was no issue with the reagent shipment as qc was performed on reagent from other shipments and the results were the same.It was noted the lab water tanks and filter cartridges were changed on or about (b)(6) 2015 which may have caused or contributed to the issue.

Manufacturer Narrative

A specific root cause could not be identified.As it was noted the issue disappeared after the account replaced the water tank, the event was likely due to water contamination.

• Brand Name: COBAS 6000 C501 MODULE
• 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: 5017512
• MDR Text Key: 23530637
• Report Number: 1823260-2015-03993
• Device Sequence Number: 0
• Product Code: CDT
• 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
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/29/2015
• 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