inforMED
DeathJRE

CHEMSTRIP 10 UA

Received May 6, 2002 · Event occurred Apr 24, 2002

Report 1823260-2002-00133 · MDR key 392686

Device

Generic name

Urinalysis Test Strip

Manufacturer

Roche Diagnostics

Model number

NA

Catalog number

418003

Lot number

28830241

Product problems

  • False Reading From Device Non-Compliance

Patient

NA

  • Death

Narrative

Description of Event or Problem

PT BROUGHT TO ER. URINE SAMPLE RAN ON SUSPECT DEVICE. RESULT OF NEGATIVE LEUKOCYTES. RAN VISUALLY AND NEGATIVE LEUKOCYTES. PERFORMED MICROSCOPIC EXAMINATION AND 40-50 GRANULOCYTES. PT EXPIRED. TOXIC LEVELS OF ACETAMINOPHEN FOUND IN BLOOD. PT ALSO TESTED POSITIVE FOR OPIATES.

Remedial action

  • Replace