inforMED
MalfunctionPZI

STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Received Oct 21, 2019 · Event occurred Sep 24, 2019

Report 1219029-2019-00054 · MDR key 9215867

Device

Generic name

Glucose Test System

Model number

54794

Catalog number

54790

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

NO PATIENT IMPACT OR ADVERSE EVENT REPORTED. INVESTIGATION IS ON-GOING.

Description of Event or Problem

THE STATSTRIP HOSPITAL METER, SN (B)(4) , READ THE PATIENT'S ARMBAND (B)(6) INSTEAD OF (B)(6). NO PATIENT RESULTS WERE REPORTED UNDER WRONG ID . NO PATIENT IMPACT OR ADVERSE EVENT REPORTED.