STATSTRIP
Received May 27, 2026 · Event occurred Apr 23, 2026
Report 1219029-2026-00034 · MDR key 25298946
Device
Generic name
Glucose Monitoring System Ivd, Point-of-care
Manufacturer
Nova Biomedical CorporationCatalog number
42214
Lot number
0325252249
Product problems
- Unable to Obtain Readings
- Output Problem
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DHR REVIEW WAS PERFORMED FOR THE REPORTED TEST STRIPS. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. IT WAS NOTED BY THE REPORTER THAT THE ISSUE WAS RESOLVED WITH THE REPLACEMENT OF A NEW TEST STRIP LOT NUMBER. THIS COMPLAINT IS BEING FURTHER INVESTIGATED BY NOVA AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
THE CONSUMER WAS UNABLE TO GET A BLOOD GLUCOSE ON THE PATIENT BECAUSE THE TEST STRIPS WERE NOT PULLING THE BLOOD UP IN TO COMPLETE THE TEST. IT WAS REPORTED THAT NOT BEING ABLE TO TEST THE BLOOD SUGAR OF THE PATIENT WAS INTERFERING WITH THEIR CARE.