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

Model Number E602

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of erroneous results for 1 patient sample tested for elecsys total psa immunoassay (total psa) on a cobas 8000 e 602 module.The initial total psa result was 11 ng/ml.This result was reported outside of the laboratory where it was questioned by the physician.The sample was repeated on the same instrument and the result was 0.04 ng/ml.The sample was also repeated on a 2nd e602 module and the result was 0.04 ng/ml.The results of 0.04 ng/ml were believed to be correct.The customer doesn¿t believe the patient received any treatment based on the initial result released from the laboratory.The physician stated the patient was under a cursory review and the results were being reviewed but no action had been taken yet.There was no allegation that an adverse event occurred.The total psa reagent lot number was 21602700.The expiration date was not provided.The field service engineer (fse) visited the customer site and did not identify an issue.An analyzer baseline check was performed and no abnormalities were noted.Instrument tests passed.The customer ran quality controls within the acceptable ranges.

Manufacturer Narrative

Total psa reagent expiration date was (b)(6) 2018.Calibration signals from (b)(6) 2017 and (b)(6) 2017 were lower than expected.No issues were identified during a review of the alarm trace.The measuring cell of the instrument was installed in (b)(6) 2016.

Manufacturer Narrative

A specific root cause was not identified.Possible root causes may be dirt on the gripper finger or contamination.Additional possible root causes for this event may be insufficient electromagnetic interference lab compliance, sample quality, insufficient maintenance, or contamination of the environment with the analyte.A general product problem has been excluded.

Manufacturer Narrative

The customer has not had any further 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: 7029016
• MDR Text Key: 93106774
• Report Number: 1823260-2017-02603
• 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,Followup,Followup,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• 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
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR