STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Jun 12, 2025 · Event occurred May 16, 2025
Report 1219029-2025-00019 · MDR key 22194102
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Nova Biomedical Corp.Model number
1.86Catalog number
54802
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
APPLICATIONS SUPPORT REACHED OUT TO THE CUSTOMER ON 7/14/2025 TO FOLLOW UP ON THIS COMPLAINT, HOWEVER THE CUSTOMER WAS UNABLE TO RECALL THE INCIDENT AND COULD NOT PROVIDE ANY FURTHER DETAILS. NO FURTHER INFORMATION IS EXPECTED TO BE FORTHCOMING. TO DATE, THE PRODUCT HAS NOT BEEN RETURNED TO NOVA FOR EVALUATION. WITHOUT THE RETURNED PRODUCT , OR FURTHER DETAILS FROM THE CUSTOMER, A DETAILED INVESTIGATION ON THE FAILED PRODUCT COULD NOT BE PERFORMED, AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THIS COMPLAINT FILE SHALL BE CLOSED AS UNCONFIRMED AT THIS TIME. IF THE PRODUCT IS RETURNED, THE COMPLAINT SHALL BE RE-OPENED. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND COMPLIANCE PRIOR TO APPROVING THE PRODUCT FOR DISTRIBUTION. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.
Additional Manufacturer Narrative
ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING ANY ADVERSE EFFECTS TO THE PATIENT HAVE NOT BEEN SUCCESSFUL. INVESTIGATION ANTICIPATED BUT NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON CONCLUSION OF TESTING.
Description of Event or Problem
DISCREPANT GLUCOSE RESULTS ON A PATIENT USING A NOVA STATSTRIP GLUCOSE METER.