MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Model Number E MODULE

Device Problem Low Test Results (2458)

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

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable low elecsys insulin results for seven patient samples that were tested throughout a batch of 180 patient samples.The samples were repeated on a cobas 6000 e 601 module.None of the erroneous results were reported outside the laboratory.There was no allegation of an adverse event.The reagent lot number was 215871.The expiration date was requested but was not provided.All qc results on the day of the event were within the acceptable range.A specific root cause could not be identified.Review of the provided analyzer alarm data found many "abnormal sample aspiration" alarms during the time of the event.The most likely cause was an issue with the sample pipetting caused by a too low sample volume or foam/air bubbles on the sample surface.A general reagent or instrument issue could be excluded based on the provided calibration, qc, and analyzer performance data.Other typical causes for this type of event include issue with sample quality or insufficient maintenance of the analyzer.

• Brand Name: ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER
• 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: 6792563
• MDR Text Key: 83312324
• Report Number: 1823260-2017-01691
• Device Sequence Number: 0
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K961481
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E MODULE
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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