STATSTRIP GLUCOSE TEST STRIPS
Received Oct 1, 2025 · Event occurred Jul 29, 2025
Report 1219029-2025-00022 · MDR key 23191276
Device
Generic name
Glucose Oxidase, Glucose
Manufacturer
Nova Biomedical Corp.Catalog number
42214
Lot number
0325037249
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
PRODUCT IN QUESTION WAS NOT RETURNED FOR INVESTIGATION. RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325037249) WERE USED FOR THE COMPLAINT INVESTIGATION. TESTING INCLUDED FIVE (5) LEVELS OF WHOLE BLOOD SPECIMENS COLLECTED FROM CONSENTING ADULTS. FIVE (5) NOVA STATSTRIP GLUCOSE METERS WERE USED FOR THE STUDY. FOUR (4) MEASUREMENTS WERE PERFORMED ON EACH METER FOR EACH SAMPLE (20 MEASUREMENTS TOTAL). PLASMA YSI GLUCOSE RESULTS WERE USED AS REFERENCE VALUES FOR THE WHOLE BLOOD SPECIMENS. RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325037249) MEET THE PERFORMANCE ACCEPTANCE CRITERIA FOR BLOOD SPECIMENS FOR TESTING DONE USING RETAINED NOVA STATSTRIP GLUCOSE METERS. THERE WAS NO DISCREPANT VALUES OBTAINED DURING THE TESTING OF RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0325037249). A ROOT CAUSE COULD NOT BE CONCLUSIVELY IDENTIFIED BASED ON THE INFORMATION PROVIDED. THE FOLLOWING ARE RECOMMENDATIONS WERE PROVIDED TO THE CUSTOMER TO ENSURE QUALITY BEDSIDE GLUCOSE TESTING RESULTS ON NEONATES: · CONTROL PRE-ANALYTICAL ERROR - REINFORCE PROPER SPECIMEN COLLECTION TECHNIQUE, INCLUDING HEEL- WARMING, LANCET SIZE AND TYPE, AND AVOIDANCE OF EXCESSIVE SQUEEZING OR MILKING. · UNDERSTAND THE BIOLOGIC VARIABILITY THAT WILL BE PRESENT WHEN SAMPLES ARE TAKEN AT DIFFERENT TIMES OR FROM DIFFERENT SITES. · HAVE AN AWARENESS OF THE INHERENT IMPRECISION OF THE BGMS. · UNDERSTAND THE ROLE OF INTERFERING AGENTS IN BGMS. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED ON THE REPORTED STRIP LOT. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.
Description of Event or Problem
BLOOD GLUCOSE VALUES ON NEONATE PATIENTS ARE INCONSISTENT CAUSING ADMISSIONS TO NICU WHEN MAYBE NOT NECESSARY. PATIENTS TREATED FOR HYPOGLYCEMIA CAUSING SOME ADMITTED TO NICU CAUSING UNNECESSARILY LONG STAYS.
Additional Manufacturer Narrative
THE SCOPE AND DEPTH OF INVESTIGATION TO BE DETERMINED BASED ON AVAILABILITY OF PRODUCT IN QUESTION FOR RETURN ANALYSIS. UPON COMPLETION OF INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED.