ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT
Received Sep 4, 2015 · Event occurred Aug 31, 2015
Report 2432235-2015-00386 · MDR key 5057461
Device
Generic name
Advia Chemistry Total Bilirubin_2 Reagent
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENTCatalog number
10341115
Lot number
327280
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SIEMENS CUSTOMER CARE CENTER (CCC) HAS NOTIFIED THE CUSTOMER THAT THE ADVIA CHEMISTRY TOTAL BILIRUBIN_2 ASSAY HAS NOT BEEN VALIDATED WITH NEONATAL SAMPLES AND IS NOT APPROVED BY THE FDA FOR TESTING WITH NEONATAL SAMPLES. THE CUSTOMER INFORMED CCC THAT THEY WERE AWARE OF THIS CLAIM. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
THE CUSTOMER IS RUNNING NEONATAL SAMPLES FOR TOTAL BILIRUBIN_2 (TBIL_2) ON AN ADVIA CHEMISTRY 1800 INSTRUMENT. A NEONATAL SAMPLE RUN ON THE ADVIA CHEMISTRY 1800 INSTRUMENT GAVE A DISCORDANT RESULT AND THE INFANT WAS HOSPITALIZED. AFTER ADMISSION TO THE HOSPITAL THE TEST WAS REPEATED AGAIN ON THE PATIENT (NEW BLOOD DRAW) AND WAS WITHIN THE EXPECTED RANGE. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS ACCEPTABLE. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT FOR TOTAL BILIRUBIN ON THE PATIENT SAMPLE.