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 Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable low elecsys testosterone ii assay result for one patient sample.The initial result was 698.1 ng/dl and the repeat result from another aliquot of the sample was 1470 ng/dl.It was unknown if the erroneous result was reported outside of the laboratory.Clarification was requested but was not provided.There was no allegation of an adverse event.The reagent lot number was 191053.The expiration date was requested but was not provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Possible causes include the non-use of rack adapters or a pre-analytical issue.Other typical causes for this type of event include issues with sample quality or insufficient maintenance of the analyzer.

Manufacturer Narrative

Clarification was received that the customer believed the result of 698.1 ng/dl to be correct, but could not confirm.The customer reported both results for the patient.

• 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: 7016975
• MDR Text Key: 92749895
• Report Number: 1823260-2017-02577
• Device Sequence Number: 0
• Product Code: CDZ
• 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,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• 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: 10/19/2017
• 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