ACCEAVA MONO TEST STRIP 25T (92404)
Received Feb 6, 2020
Report 2027969-2020-00011 · MDR key 9679340
Device
Generic name
Mononucleosis Rapid Test
Manufacturer
Alere San Diego, Inc.Model number
IMO-411Lot number
NOT PROVIDED
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INTAKE UNABLE TO SPEAK WITH CUSTOMER DIRECTLY. KIT NOT BEING RETURNED. RESULTS PENDING INVESTIGATION.
Description of Event or Problem
UNSPECIFIED DATE: CUSTOMER REPORTS THE GLASS CAPILLARY TUBES PROVIDED IN THE ACCEAVA MONO II TEST KIT FREQUENTLY BREAK WHEN ATTEMPTING TO COLLECT THE SAMPLE FROM THE PATIENT. NO FURTHER INFORMATION AVAILABLE. INTAKE WAS UNABLE TO SPEAK TO THE CUSTOMER DIRECTLY; ISSUE WAS REPORTED BY AN ABBOTT REPRESENTATIVE. NO KNOWN IMPACT TO THE OPERATOR OR PATIENT. ALTHOUGH NO DEATH OR SERIOUS INJURY WAS REPORTED AT INTAKE, AS THE CAPILLARY TUBE IS GLASS AND CONTAINS PATIENT SPECIMEN, THERE IS THE POTENTIAL FOR HARM IF THE ISSUE WERE TO RECUR. THEREFORE, THIS MDR IS BEING CONSERVATIVELY FILED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
BASED ON MEDICAL REVIEW AND INPUT, BREAKAGE OF THE CAPILLARY TUBES WHILE COLLECTING SAMPLE FROM A FINGERSTICK WOULD NOT CAUSE ANY ADVERSE EVENT, DEATH OR SERIOUS INJURY, THEREFORE, THIS SERIOUS INJURY MDR WAS FILED IN ERROR. PLEASE DISREGARD MDR.
Description of Event or Problem
BASED ON MEDICAL REVIEW AND INPUT, BREAKAGE OF THE CAPILLARY TUBES WHILE COLLECTING SAMPLE FROM A FINGERSTICK WOULD NOT CAUSE ANY ADVERSE EVENT, DEATH OR SERIOUS INJURY, THEREFORE, THIS SERIOUS INJURY MDR WAS FILED IN ERROR. PLEASE DISREGARD MDR.