MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Model Number E411 DISK

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable elecsys total psa immunoassay and/or elecsys free psa immunoassay result for two patient samples.Of the data provided, only the following results were discrepant.Patient 1 initial total psa result was >100 ng/ml.The repeat result with a 1:5 dilution was 48.76 ng/ml.The repeat result with no dilution was >100 ng/ml and the repeat result with a 1:2 dilution was 140 ng/ml.Patient 2 initial free psa result was 0.003 ng/ml.The repeat result was 0.5 ng/ml.This patient was male.No erroneous result was reported outside the laboratory.There was no allegation of an adverse event.The total psa reagent lot number was 19942201 with an expiration date of 04/30/2018.The free psa reagent lot number was 15099000 with an expiration date of 08/31/2017.The field service representative adjusted the mixer speed because he found it was creating foam in the reagents and he adjusted the position of the probe.

• Brand Name: COBAS E 411 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: 6800054
• MDR Text Key: 83750603
• Report Number: 1823260-2017-01726
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 08/17/2017

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: E411 DISK
• Device Catalogue Number: 4775279001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/17/2017
• 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