ADVIA CHEMISTRY FERRITIN REAGENTS (FRT)
Received Feb 16, 2017 · Event occurred Jan 19, 2017
Report 2432235-2017-00110 · MDR key 6335203
Device
Generic name
Advia Chemistry Ferritin Reagents (frt)
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
ADVIA CHEMISTRY FERRITIN REAGENTS (FRT)Catalog number
10494078
Lot number
380707
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND STATED THAT THEIR QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND STATED THAT THERE WAS NO REAGENT ISSUE. THE HSC SPECIALIST DETERMINED THAT THE DISCORDANT RESULTS WERE CONSISTENT WITH INTERFERENCE. AS PER THE LIMITATIONS SECTION OF ADVIA CHEMISTRY FERRITIN INSTRUCTIONS FOR USE, "AS WITH ANY CHEMICAL REACTION, YOU MUST BE ALERT TO THE POSSIBLE EFFECT ON RESULTS OF UNKNOWN INTERFERENCES FROM MEDICATIONS OR ENDOGENOUS SUBSTANCES. THE LABORATORY AND PHYSICIAN MUST EVALUATE ALL PATIENT RESULTS IN LIGHT OF THE TOTAL CLINICAL STATUS OF THE PATIENT." THE CAUSE OF INTERFERENCE ON THE PATIENT SAMPLE IS UNKNOWN. THE DEVICE IS PERFORMING AS EXPECTED. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.
Description of Event or Problem
THE CUSTOMER OBTAINED DISCORDANT, FALSELY LOW FERRITIN (FRT) RESULTS UPON INITIAL AND REPEAT TESTING ON ONE PATIENT SAMPLE WHEN TESTED ON TWO ADVIA 2400 INSTRUMENTS, WHILE USING REAGENT LOT 380707. THE CUSTOMER DILUTED THE SAMPLE AND RAN IT ON AN ALTERNATE PLATFORM WHERE THE RESULTS WERE HIGHER. A NEW SAMPLE WAS OBTAINED FROM THE SAME PATIENT AND IT WAS TESTED ON THE ADVIA 2400 INSTRUMENT AND THE ALTERNATE PLATFORM. THE RESULT OBTAINED ON THE ADVIA 2400 WAS STILL LOW, WHILE THAT ON THE ALTERNATE PLATFORM WAS HIGHER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW FRT RESULTS.