AUTODELFIA NEONATAL 17A-OH-PROGESTERONE
Received Dec 8, 2006 · Event occurred Nov 8, 2006
Report 8043909-2006-00001 · MDR key 793835
Device
Product problems
- False Negative Result
Patient
2 MO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE EVENT IS ASSOCIATED WITH THE USE OF THE AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT, WHICH IS INTENDED FOR THE QUANTITATIVE DETERMINATION OF HUMAN 17A-OH-PROGESTERONE IN BLOOD SPECIMENS DRIED ON FILTER PAPER AS AN AID IN SCREENING NEWBORNS FOR CONGENITAL ADRENAL HYPERPLASIA (CAH) USING THE 1235 AUTODELFIA AUTOMATIC IMMUNOASSAY SYSTEM. THE LAB CALLED 11/8/06 ABOUT THAT THEY HAD FOUND OUT THAT THEY HAD APPARENTLY MISSED A BABY IN THE SCREENING PROGRAM. THE BABY BECAME SICK AND WAS AT THE HOSP IN LATE OCTOBER. THE BABY IS REPORTED TO BE RECOVERING WELL. THE ORIGINAL SAMPLE TESTED IN 08/06 HAD BEEN REPORTED AS NEGATIVE, BUT WHEN RETESTED IN 11/06, IT WAS POSITIVE.
Additional Manufacturer Narrative
INITIAL INVESTIGATIONS OF THE KIT LOT CONCERNED HAS SHOWN THAT THE PRODUCT IS PERFORMING ACCORDING TO ITS SPECIFICATIONS. THEREFORE, NO RECALL NEED HAS BEEN IDENTIFIED. THE POSSIBLE ROOT CAUSE FOR THE NEGATIVE RESULT IS CURRENTLY BEING INVESTIGATED.