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 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable high elecsys anti-tshr immunoassay results for four patient samples.Of the data provided, only the results for one patient sample were discrepant.The initial result was 2.0 iu/l and the repeat result was 0.5 iu/l.The repeat result was reported outside the laboratory.There was no allegation of an adverse event.The reagent lot number was 217302-013 with an expiration date of 05/31/2018.A specific root cause could not be determined.From the information provided, a general reagent issue could most likely be excluded.As a low control value was also noted on the day of the event, an issue with the calibration was suspected.This may have been caused by incorrect pre-incubation at room temperature where the magnetic beads or the reagents were not at the correct temperature at the time the calibration or patient testing was performed.

• 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: 6833696
• MDR Text Key: 84643300
• Report Number: 1823260-2017-01871
• Device Sequence Number: 0
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/31/2017

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: 08/10/2017
• Initial Date FDA Received: 08/31/2017
• 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