Name *

Email *

Phone *

Resume  

Cover Letter  

Are you a?CustomerPatientField RepresentativeDistributorEngineeringClinical TrialService ReportsNeuMoDx Voluntary Reports

Contact Details

Name of Person/Organization *

Street Name and No *

City and Post Code *

Country *

Telephone *

Email *

Did you experience the Issue?YesNo

User facility/reporting organization report reference number (if applicable):

General Information

Report Type (check all that apply)DeathSerious adverse eventAdverse event (not serious)Product Problem (defects/malfunctions)Out of service/safety issueProduct use errorLabeling issue

Date of Event * 

Date of Death (if applicable) 

Describe event/serious event/product problem/product use error in a narrative
(explain what went wrong with the product and the observed or likely/probable consequences): *

Operator/user at the end time of the event/problem:Health Professional/Lab technicianLay User/PatientOther

Use of the medical device:Initial use of assayRe-use of of instrumentRe-serviced/refurbishedProblem noted prior useDuplicate issueOther (please specify)

Has more than one user experienced the problem with the product?NoYes

Number of tests involved (if known): *

Type of specimen used (please specify): *

State reading time used: *

Number of instruments involved(if known):

Instrument/assay being used for: *TreatmentEvaluation

Type of serious device effect: *False negative resultIncorrect qualification of the infection/Unclear resultsFalse positive resultDelayed reporting of resultsOther, please specify

Number of patients involved (if known):

Troubleshooting packaged generated?NoYes

Back up data or photos available?NoYes

If available, email to: techsupport@neumodx.com (Include compliant in the subject line)

Product Details

Assay, Reagents and Consumables

Product name/brand name:

Product code (catalogue number(s)):

Lot number/batch number:

Expiration date:

Unique Identifier:

Instructions for use version number:

Instruments

Product name/brand name:

Product code (catalogue number(s)):

Serial number:

Device manufacturing date:

Unique Identifier:

Operator's manual version number:

Software version:

Firmware version:

Associated devices/accessories serial number:

Associated devices/accessories lot number (if applicable):

Current location/disposition of the instrument:

Action Taken

Immediate Action Taken by User/Facility:NoYes

By Whom:

Describe Action Taken by User/Facility:

Note for the Complaint Initiator: