MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem High Test Results (2457)

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

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received an erroneous result for one patient sample tested for the elecsys anti-tshr immunoassay (anti-tshr) on a cobas 6000 e 601 module (e601).It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The sample initially resulted as > 40 iu/l.The sample was repeated twice, resulting as 0.4 iu/l and 0.8 iu/l.No adverse events were alleged to have occurred with the patient.The anti-tshr reagent lot number and expiration date were asked for, but not provided.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.Based on the provided information, a general reagent issue is not likely.The most likely root cause is related to possible foam/bubbles on the surface of the reagent.Bubbles/foam on the reagent surface could lead to a pipetting of an insufficient amount of reagent.Another possible root cause is related to sample quality.

• Brand Name: COBAS 6000 E 601 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: 6965827
• MDR Text Key: 90763118
• Report Number: 1823260-2017-02391
• Device Sequence Number: 0
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2017

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: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/20/2017
• 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