BABY GENDER MENTOR TEST
Received Oct 29, 2005 · Event occurred Aug 5, 2005
Report MW1037898 · MDR key 747091
Device
Generic name
Gender Finding Blood Test
Manufacturer
Acu-gen LabModel number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
23 YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
REPORTER'S DAUGHTER PURCHASED THE BABY GENDER MENTOR TEST FROM ACU-GEN LAB. INSTEAD OF THE TECH CALLING TO CONFIRM THAT SHE WAS HAVING A BOY OR GIRL, THEY DIAGNOSED HER BABY, OVER THE PHONE, WITH CHROMOSONAL ABNORMALITIES. THIS TYPE OF TESTING WAS NOT SUPPOSED TO BE DONE WITH HER BLOOD SAMPLE, NOR SHOULD SHE HAVE BEEN NOTIFIED BY A COMPLETE STRANGER, WHO CLAIMS TO BE A DR, VIA TELEPHONE, TO BE TOLD SOMETHING OF THIS NATURE. THE ADVERTISEMENT FOR THIS TEST, ONLY STATES THAT THEY WILL CHECK FOR THE BABIE'S "GENDER", NOTHING ELSE. REPORTER'S DAUGHTER'S OB DR HAS DONE TESTS AT THE CORRECT TIME, FOR "RELIABLE" RESULTS, AND HAS FOUND NOTHING WHATEVER WRONG WITH HER BABY TO DATE.