MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Aug 15, 2019 · Event occurred Jul 10, 2019
Report 1219029-2019-00040 · MDR key 8898230
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical Corp.Model number
42214Lot number
0318309219
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 ADVERSE EVENT REPORTED, INVESTIGATION IN PROCESS.
Description of Event or Problem
(B)(6) 2019: DISCREPANT GLUCOSE PATIENT RESULTS FOR HEELSTICK USING NOVA STATSTRIP HOSPITAL METER WHEN COMPARED TO LAB REFERENCE ANALYZER. NO ADVERSE EVENT REPORTED, PEDIATRICIAN QUESTIONED THE STATSTRIP RESULTS BASED ON LAB REFERENCE ANALYZER RESULTS.