MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E801

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned results for 2 patient samples tested for elecsys brahms pct (pct) on a cobas e 801 module.The customer has had ongoing issues with imprecise pct results.Based on the data provided, the results for 1 patient were erroneous.It is not known if erroneous results were reported outside of the laboratory.The initial pct result from the e801 module was 6.18 ng/ml.The sample was repeated 4 times on the e801 module with results of 7.00 ng/ml, 8.69 ng/ml, 9.91 ng/ml and 13.4 ng/ml.The customer sent the sample to an external laboratory and the result was 8.69 ng/ml.There was no allegation that an adverse event occurred.The pct reagent lot number was 204084.The expiration date was not provided.The customer¿s calibration data from 24-aug-2017 does not suggest any issues.The customer¿s quality control (qc) results could not be assessed as the lot number was invalid and the results were implausible.The customer uses a sample volume of 0.7 ml which is much too low for a 4 ml sample tube.The customer does not perform tube inversions.The customer uses a centrifugation time of 5 minutes at 3500 rpm.The relative centrifugal force (rcf) was not provided.The customer¿s centrifugation time of 5 minutes may be inadequate as most tubes need a centrifugation time of 5-15 minutes.The customer uses rack adapters.A specific root cause was not identified.Additional information was requested for investigation but was not provided.Potential root causes may be related to the sample volume and other pre-analytical issues such as centrifugation time and the lack of sample mixing.Additional possible root causes may be insufficient electromagnetic interference lab compliance, sample quality, insufficient maintenance, or contamination of the environment with the analyte.

• Brand Name: COBAS 8000 E 801 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: 6943823
• MDR Text Key: 90336413
• Report Number: 1823260-2017-02280
• Device Sequence Number: 0
• Product Code: PMT
• 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
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E801
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1