User complaint form for adverse events and product problems

advertisement
Diagnostics and Laboratory
Technology
USER COMPLAINT FORM FOR
REPORTING PROBLEMS AND/OR ADVERSE EVENTS RELATED TO DIAGNOSTIC
PRODUCTS
Send to:
WHO Prequalification of Diagnostics,
World Health Organization, 20 Avenue Appia CH-1211, Geneva 27 Switzerland
Fax: +41 22 791 48 36 Email: [email protected]
WHO Internal Use Only
Report Number:
Date received at DLT:
1. Contact details of the reporting person/organization
Name of organization:
Street Name and No.:
City and postcode:
Country:
Telephone:
Fax:
Name and position of contact person:
Email of contact person:
2. Product details
Product name/commercial name/brand
name:
Catalogue number:
Serial number/batch number/lot number:
Expiry date:
Associated devices/accessories:
Instructions for use version number:
Distributor name and address:
Manufacturer name and address:
Please attach a copy of the instructions for use
PQDx_118 v3 21 November 2011
3. Event/problem details
Event/problem description narrative (explain what went wrong with the product and the observed
or likely/probable consequences1):
Date and place of the event/problem:
Number of tests involved :
Are tests from different kits involved?
□ Yes
□ No
% of tests involved 2:
Operator at the time of the event/problem
(please choose):
□ Laboratory technician/technologist
□ Non-laboratory trained health worker
Has more than one operator experienced the problem
with the product?
□ Yes
□ No
Type of specimen used (please specify):
Reading time observed:
Have you informed the distributor?
□ Yes
□ No
Date:
Have you informed the manufacturer?
□ Yes
□ No
Date:
What measures have been recommended?
What measures have been recommended?
Measures taken by the user:
Date of report:
1
2
Signature:
Documents providing additional information can be attached to this form
Please clarify how many tests out of the total number of tests used have a problem
PQDx_118 v3 21 November 2011
Page 2 of 2
Download
Related flashcards
Complex analysis

23 Cards

Create flashcards