HEMASTIX
Received May 26, 2025 · Event occurred Feb 21, 2025
Report 3002637618-2025-00038 · MDR key 22084054
Device
Generic name
Hemastix
Manufacturer
Siemens Healthcare Diagnostics Inc.Catalog number
10484765
Lot number
402007
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULT IN THEIR HEMASTIX COMPARED TO RETEST PERFORMED ON THE NOVUS DEVICE. THE PATIENT'S BLOOD RESULT WAS CONFIRMED FROM THE REPEAT TESTING. THERE IS NO REPORTED INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED RETURN OF REAGENT FOR FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.
Additional Manufacturer Narrative
SIEMENS HAS OBTAINED RETURNED REAGENT FROM THE CUSTOMER AND COMPLETED THE INVESTIGATION. THIRTEEN TEST STRIPS WERE TESTING USING SAMPLES WITH POSITIVE BLOOD AND NO FALSE NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER'S ALLEGATION WAS NOT OBSERVED. THE CAUSE OF THE EVENT IS UNKNOWN.