inforMED
InjuryKHG

ANEMOCHECK

Received Mar 26, 2024 · Event occurred Mar 1, 2024

Report MW5153212 · MDR key 18987021

Device

Generic name

Whole Blood Hemoglobin Determination

Manufacturer

Sanguina, Inc.

Patient

73 YR · Female

  • Anemia
  • Anemia

Narrative

Description of Event or Problem

I DEPENDED ON FDA APPROVED ANEMOCHECK BY SANGUINA TO MONITOR MY HEMOGLOBIN FROM CHRONIC BLEEDING DUE TO GASTRIC AVMS (ARTERIOVENOUS MALFORMATIONS). EVEN AFTER CALIBRATING WITH THE LAB IT WAS GIVING ME READINGS IN THE RANGE OF 12 TO 14. I FINALLY REALIZED I WAS IN CRISIS WHEN MY HEMOGLOBIN REACHED 6 AND THE MONITOR WAS STILL READING IN THE 13 TO 14 RANGE. I HAD TO HAVE AN EMERGENCY TWO UNITS OF BLOOD. IF I HADN'T DEPENDED ON THIS TECHNOLOGY I WOULD HAVE GONE IN SOONER AND BEEN ABLE TO GET IRON INFUSIONS INSTEAD OF BLOOD. IT REACHED A LOW OF 6.3 BEFORE RECEIVING BLOOD TRANSFUSIONS.