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 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of questionable results for one patient sample tested for elecsys brahms pct.The patient had three separate samples drawn on three consecutive days.Only one sample had a reportable malfunction when comparing the results from their cobas 6000 e 601 module versus another laboratories abbott analyzer and another laboratories cobas analyzer.The initial pct result was 74.47 ng/ml.The sample was sent to an outside laboratory and tested on a abbott analyzer with a pct result of 44.29 ng/ml.The sample was then sent to another outside laboratory and tested on a cobas analyzer on (b)(6) 2018 with a pct result of 49.60 ng/ml.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.Control materials that were tested around the same time of event were in acceptable range.The brahms pct reagent lot was 17750601 with an expiration date of 30-apr-2018.The investigation is currently ongoing.

Manufacturer Narrative

The patient was given antibiotic treatment but it is not known if the patient has sepsis.Analysis of the instrument alarm trace gave no indication of an issue.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• 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: 7299079
• MDR Text Key: 101468917
• Report Number: 1823260-2018-00571
• Device Sequence Number: 0
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• 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: 02/07/2018
• 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