InjuryNAK
NEWBORN SCREENING BLOOD-SPOT COLLECTION DEVICE
Received Sep 29, 2010 · Event occurred Sep 22, 2010
Report MW5017623 · MDR key 1852869
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
SINCE (B)(6) 2010, THE LABORATORIES ADMINISTRATION OF THE (B)(6) STATE DEPT OF HEALTH AND MENTAL HYGIENE HAS IDENTIFIED APPROXIMATELY 170 NEWBORN SCREENING TEST RESULTS FOR BIOTINIDASE DEFICIENCY WITH NO BIOTINIDASE ACTIVITY. THERE IS A POSSIBILITY THAT THESE RESULTS ARE ASSOCIATED WITH LOT W092 OF NEWBORN SCREENING BLOOD-SPOT FILTER PAPER FORMS -SPECIMEN COLLECTION DEVICES- MFG BY GE HEALTHCARE. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SCREENING NEWBORNS FOR HEREDITARY DISORDERS.