CHLAMYDIAZYME EIA
Received Oct 9, 2003 · Event occurred Sep 10, 2003
Report 1415939-2003-00025 · MDR key 489501
Device
Generic name
Eia For The Detection Of Chlamydia Antigen
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
1803-30
Lot number
04572M100
Product problems
- False Negative Result
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE ACCOUNT GENERATED NEGATIVE CHLAMYDIAZYME EIA RESULTS, REAGENT LOT 04572M100, ON 18 PATIENTS THAT TESTED BSA SLIDE TECHNIQUE POSITIVE. THIS REPORT IS FOR PATIENT 17 OF THE 18 TOTAL PATIENTS. ALTHOUGH THE CONTROL VALUES WERE ACCEPTABLE, THE ACCOUNT NOTICED A BIG DROP IN THE POSITIVE RESULT VALUES. THE ACCOUNT RETESTED THE PATIENTS USING CHLAMYDIAZYME EIA REAGENT LOT 03228M100 WITH THE EXPECTED POSITIVE RESULTS. AMENDED REPORTS WERE SUBMITTED TO THE PHYSICIANS. IT IS UNKNOWN IF THERE WAS IMPACT TO PATIENT MANAGEMENT. NO PATIENT INFORMATION IS AVAILABLE.