MalfunctionPZI

STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Received Jun 6, 2019 · Event occurred Apr 24, 2019

Report 1219029-2019-00011 · MDR key 8676540

Device

Generic name

Glucose Test System

Manufacturer

Nova Biomedical Corp.

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

NOVA BIOMEDICAL IS AWAITING ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE INCIDENTS. THE CUSTOMER RETURNED THE BARCODES TO NOVA FOR EVALUATION. INVESTIGATION ONGOING.

Description of Event or Problem

ON (B)(6) 2019: NOVA STATSTRIP HOSPITAL METER MISREAD A BARCODE AT 12:06 INCORRECTLY. BARCODE WAS FOR (B)(4) BUT METER READ (B)(4). ANOTHER NOVA STATSTRIP HOSPITAL METER ALSO MISREAD TWO BARCODES AT 8:08 AND 9:34.