MalfunctionQGU

THUMB HGB MONITOR

Received Jan 7, 2025 · Event occurred Jan 4, 2025

Report MW5164404 · MDR key 21104936

Device

Generic name

Hemoglobin For Donor Testing

Manufacturer

Orsense Ltd.

Patient

64 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE BLOOD CENTER'S USE OF AN ORSENSE THUMB HGB MONITOR GAVE FALSE READINGS AND PREVENTED PATIENT FROM DONATING BADLY NEEDED BLOOD. SPECIFICALLY, (B)(6) 2024, ORSENSE 11.6 G/DL HGB, AND (B)(6) 2025 12.4 G/DL. IN CONTRAST, A LAB BLOOD DRAW/CBC(COMPLETE BLOOD COUNT) ON (B)(6) 2024 GAVE A HGB LEVEL OF 14.0 G/DL. THIS INACCURACY COULD AFFECT MANY OTHER PATIENTS AND REDUCE AVAILABILITY OF BLOOD DONATIONS. PATIENT HAS NO HISTORY OF ANEMIA AND NO SYMPTOMS OF ANEMIA. REF REPORT: MW5164405.