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

Model Number E602

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 1 patient sample tested for elecsys free psa immunoassay (free psa) on 3 cobas 8000 e 602 modules.Results were not reported outside of the laboratory.It is not known which results were believed to be correct.This medwatch will cover e602 module serial number (b)(4).Refer to medwatch with patient identifier (b)(6) for information on the erroneous result from e602 module serial number (b)(4) and medwatch with patient identifier (b)(6) for information on the erroneous result from e602 module serial number (b)(4).The initial free psa result on e602 module with serial number (b)(4) was 0.011 ng/ml.The sample was repeated on e602 module serial number (b)(4) and the result was 0.671 ng/ml.The sample was repeated on e602 module serial number (b)(4) and the result was 0.787 ng/ml.Based on the data provided, there is an additional patient sample with erroneous free psa results.It is not clear whether this additional sample is from the 1 patient the customer complained about or if this is for a different patient.It is also not known which e602 module produced the results.Clarification on this has been requested but has not been provided.The initial free psa result was 0.01 ng/ml.The repeat result was 0.395 ng/ml.It is not known which result is believed to be correct.This information was requested but has not been provided.There was no allegation that an adverse event occurred.The free psa reagent lot number and expiration date were not provided.A specific root cause was not identified.Additional information was requested for investigation but was not provided.The customer has not provided any additional information related to this event, therefore the investigation could not be completed.A general product problem is excluded.

• 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: 7037798
• MDR Text Key: 93348595
• Report Number: 1823260-2017-02633
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100853
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: ASKU
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1