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 08/01/2017

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 an unknown number of patient samples.A new reagent pack was prepared and loaded onto the analyzer, calibration and quality control were performed which were acceptable, so patient samples were tested and the results reported outside the laboratory.The reported results were questioned so the customer repeated the quality control again and it was within the acceptable range.The customer prepared new reagent, checked the quality control, and retested the patient samples.The results were lower than the previous results.Of the data provided for 26 patient samples, only the results for 18 were discrepant.Refer to the attachment to the medwatch for all patient data.There was no allegation of an adverse event.The reagent lot number was 217302.The expiration date was requested but was not provided.The customer suspected an issue with the reagent which was submitted for investigation.The provided reagent and retention material were compared and it was confirmed that there was no problem with the performance of the reagent.

Manufacturer Narrative

A specific root cause could not be determined.The issue was most likely caused by a poor calibration curve due to incorrectly prepared calibration material.Qc was not performed after the calibration and as a consequence the customer did not detect the poor calibration.

• 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: 6807545
• MDR Text Key: 83750384
• Report Number: 1823260-2017-01779
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• 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
• Date Manufacturer Received: 08/02/2017
• 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