STATSTRIP GLUCOSE METER WITH BATTERY AND QUICK REFERENCE GUIDE
Received Sep 30, 2024
Report 1219029-2024-00004 · MDR key 20332113
Device
Generic name
Blood Glucose Monitor
Manufacturer
Nova Biomedical CorporationModel number
1.86Catalog number
54790
Product problems
- Low Readings
- Low Readings
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
CORRECTION: INITIAL SUBMISSION OF MFR REPORT 1219029-2024-00004 INDICATED IN SECTION B5 THE RECEIPT OF MEDSUN REPORT (B)(4). THIS REPORT NUMBER WAS NOT CAPTURED WITHIN H10. THIS REPORT IS BEING SUBMITTED TO CORRECT THAT ERROR.
Description of Event or Problem
RECEIPT OF MEDSUN REPORT: (B)(4). GLUCOMETER WITH MULTIPLE CRITICAL LOW READINGS TRIGGERING PATIENT TO GET D10 BOLUS TO INCREASE GLUCOSE LEVELS. WHEN BLOOD SENT TO THE LAB AT THE SAME TIME, WITH NORMAL GLUCOSE LEVELS. SUSPECT GLUCOMETER ERROR AS PATIENT'S BLOOD GLUCOSE LEVELS HAVE BEEN NORMAL SINCE SENDING ALL BLOOD TO THE LAB.
Additional Manufacturer Narrative
THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. NUMEROUS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT HAVE NOT BEEN SUCCESSFUL. ADDITIONAL INFORMATION NOT EXPECTED TO BE FORTHCOMING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, NOVA BIOMEDICAL WILL RE-EVALUATE COMPLAINT DETAILS. THE PRODUCT INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT. UDI INFORMATION NOT ABLE TO BE PROVIDED. SPECIFIC DETAILS REGARDING THE EVENT AND PATIENT IMPACT COULD NOT BE OBTAINED. 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 BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.