MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number 04745922001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of questionable results for 3 patient samples tested for total (free + complexed) psa - prostate-specific antigen (tpsa) - total psa.The erroneous result for 1 patient was reported outside of the laboratory.The initial total psa result was 0.014 ng/ml.This result was reported outside of the laboratory.On (b)(6) 2015 the patient complained about the result.The sample was repeated and the result was 5.23 ng/ml.A new sample was obtained on (b)(6) 2015 and the total psa result was 5.26 ng/ml.No adverse event occurred.The patient is listed as being fine.The total psa reagent lot was 181675 with an expiration date of 01/2016.The customer had last performed calibration on (b)(6) 2015.It was noted that this is not frequent enough according to manufacturer recommendations.It was noted that quality controls were not performed on the day of the event.Upon review of the alarm trace, an instrument issue was not identified.Potential root causes may be related to pre-analytics.The customer uses 13 mm tubes without rack adapters.The sample tube may not have been placed correctly in the rack.There may have been bubbles/foam on the reagent surface.Quality controls would have detected this; however, they were not run on the day of the event.

Manufacturer Narrative

A specific root cause could not be identified.The customer was advised to have an instrument check performed, perform calibration on a regular basis per manufacturer recommendations, perform quality controls before running samples each day, use rack adapters for 13 mm tubes, and check reagent surface for bubbles/foam.

• Brand Name: COBAS 6000 E601 MODULE
• Type of Device: IMMUNOCHEMISTRY 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: 5210454
• MDR Text Key: 30717315
• Report Number: 1823260-2015-04463
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• 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
• Patient Age: 066 YR