N LATEX HCY

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS HAS OBSERVED A REDUCED ONCE-OPENED STABILITY AND A REDUCED ON-BOARD STABILITY FOR THE AFFECTED LOT 802907632 THAT MAY RESULT IN ERRONEOUSLY REDUCED OR ELEVATED HOMOCYSTEINE. THIS STABILITY ISSUE MAY LEAD TO A HIGHER THAN EXPECTED LOT-TO-LOT VARIATION AND IMPAIRED PRODUCT PERFORMANCE. URGENT MEDICAL DEVICE CORRECTION (UMDC) (B)(4) WAS SENT TO CUSTOMERS IN THE UNITED STATES ON JANUARY 11, 2017 AND CORRESPONDING URGENT FIELD SAFETY NOTICE (UFSN) (B)(4) WAS SENT TO ALL OUTSIDE US CUSTOMERS WHO HAVE BEEN SHIPPED THE IMPACTED LOT, 802907632. THE UMDC AND UFSN TITLED "N LATEX HCY AND N LATEX HCY (BCS® XP) LOT 802907632 DOES NOT MEET ONCE-OPENED AND ONBOARD STABILITY CLAIMS" AND INSTRUCTS CUSTOMERS TO DISCONTINUE USE AND TO DISCARD THE LOT.

Description of Event or Problem

A DISCORDANT LOW HOMOCYSTEINE (HCY) RESULT WAS OBTAINED ON A PATIENT SAMPLE WITH LOT 802907632 IN A LOT TO LOT COMPARISON STUDY ON THE BN PROSPECT INSTRUMENT. THE PATIENT RESULT FROM LOT 802907632 WAS REPORTED TO THE PHYSICIAN. FIVE ADDITIONAL SAMPLES WERE SIMILARLY LOW WITH LOT 802907632. ALL CONTROLS RUN WITH HCY REAGENT LOTS 802907632 AND 802909289 WERE WITHIN THE NORMAL RANGES AND NO INSTRUMENT ERRORS WERE FOUND WITH THE SYSTEM. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HCY RESULTS.