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

Model Number E MODULE

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable elecsys vitamin b12 immunoassay and folate results.The customer had experienced qc imprecision and tested the patient samples in duplicate.No data was provided for the folate issue.Of the vitamin b12 data provided for 70 patient samples, only the results for six were discrepant.Information concerning if any of the results were reported outside the laboratory was requested, but it was unknown.There was no allegation of an adverse event.The vitamin b12 reagent lot number was 23140100.The expiration date was requested but was not provided.The customer only runs this module twice a week.In between, the customer tests clinical trial samples if they are available.If not available, the system is shut down.The customer did not centrifuge the samples after they were thawed and vortexed.The customer was also not using the sample tube adapters recommended for use with 13x75 mm tubes.The field service representative checked the analyzer and found no issues.A precision check was performed.

Manufacturer Narrative

The field service representative found that the prewash station adjustment was not acceptable and corrected it by adjusting the prewash magnets.He ran analyzer performance testing.Upon follow up, the customer confirmed there were no further issues.

• 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: 6647766
• MDR Text Key: 77875414
• Report Number: 1823260-2017-01260
• Device Sequence Number: 0
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• 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: 06/02/2017
• 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