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.