inforMED
MalfunctionLCX

SCANTIBODIES LABORATORY, INC.

Received Nov 24, 2003 · Event occurred Nov 15, 2003

Report MW1030368 · MDR key 499033

Device

Generic name

First Response Early Result Preg

Model number

*

Catalog number

*

Lot number

*

Product problems

  • False Positive Result

Patient

36 YR

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

FIRST RESPONSE EARLY RESPONSE PREGNANCY DOUBLE PACK WITH BONUS TEST GAVE REPORTER A FALSE POSITIVE TEN DAYS AFTER OVULATION. CONFIRMATION WITH OTHER BRANDS AND A BETA TEST AND SUBSEQUENT MENSTRUATION CONFIRMED REPORTER IS NOT PREGNANT.