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 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous high results for 15 patient samples tested for elecsys afp assay (afp) on a cobas 8000 e 602 module.The erroneous results were reported outside of the laboratory.Refer to the attached data for patient results.There was no allegation that an adverse event occurred.The afp reagent lot number was 192075 with an expiration date of 31-aug-2018.

Manufacturer Narrative

The afp reagent lot number was 21371600.Serial number was updated.Calibration and quality controls were acceptable.

Manufacturer Narrative

A specific root cause was not identified.Additional information was requested for investigation but was not provided.The repeat results for each patient were believed to be correct.The initial and repeat results were from the same primary tube.Afp is a high priority test.Since the results were from the same primary tube, a potential carry-over issue influencing the results cannot be excluded.No special maintenance was performed on the instrument between the initial and repeat results.The customer did not have issues with other assays and the issue has not recurred.Based on the available information, an afp assay related issue is not suspected.Possible root causes of the issue may be dirt on the gripper finger or poor sample quality.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: 6951040
• MDR Text Key: 90551096
• Report Number: 1823260-2017-02316
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 02/05/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• 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: 09/28/2017
• 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