MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received a call from an external site questioning results from 1 patient sample tested for elecsys total psa immunoassay (total psa) and elecsys free psa immunoassay (free psa).Erroneous results were identified when the customer repeated the sample on (b)(6) 2016.The initial results had been reported outside of the laboratory and a corrected report was provided after the repeat results were obtained.The initial total psa result was 0.010 ng/ml.On (b)(6) 2016 the repeat result was 4.22 ng/ml.The initial free psa result was 0.010 ng/ml with a data flag.On (b)(6) 2016 the repeat result was 1.14 ng/ml.A new sample was obtained from the patient on (b)(6) 2016 and the total psa result was 4.29 ng/ml and the free psa result was 0.93 ng/ml.No adverse event occurred.The total psa reagent lot number was 18561201 with an expiration date of 09/30/2016.The free psa reagent lot number was 18843701 with an expiration date of 02/28/2017.The customer did not inspect the tube before loading onto the device; it is not known if there was foam on the sample or not.The field service engineer visited the customer site.No issues were identified.Multiple parts of the instrument were checked for proper alignment, rinsing and dispensing.Analyzer tests were performed and all results were within specification.A specific root cause could not be identified.Additional information was requested for investigation but was not provided.Quality control results prior to and after the erroneous result were acceptable.The customer did not use rack adapters.Based on a review of the alarm trace from 09/15/2016, several abnormal sample aspiration messages were identified.This suggests pre-analytical issues with the sample or pipetting issues.Since no rack adapter was used, a potential root cause is a pipetting issue that led to the low results.This can be caused by a tilted tube, a slightly misaligned sample probe or wet tube walls.The customer has not had any additional issues.

• Brand Name: COBAS 8000 E 602 MODULE
• Type of Device: IMMUNOCHEMISTRY 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: 5999310
• MDR Text Key: 56450154
• Report Number: 1823260-2016-01517
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 10/05/2016

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: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/05/2016
• 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: 67 YR