BN II / BN PROSPEC® SYSTEM
Received Nov 2, 2016 · Event occurred Sep 1, 2016
Report 9610806-2016-00030 · MDR key 6072324
Device
Generic name
N Antisera To Human Immunoglobulins (igg, Iga And Igm)
Manufacturer
Siemens Healthcare Diagnostics Products GmbhCatalog number
OSAR
Lot number
153022D
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CAUSE OF THE FALSELY ELEVATED IGG RESULTS IS UNKNOWN. SIEMENS HEALTHCARE HEADQUARTERS SUPPORT CENTER AND TECHNICAL SUPPORT LABORATORY REPRESENTATIVES EVALUATED THE DATA AVAILABLE. NO SYSTEMIC INSTRUMENT OR REAGENT ISSUES WERE IDENTIFIED. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
FALSELY ELEVATED IMMUNOGLOBULIN G (IGG) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE BEHRING NEPHELOMETER II (BN-II) INSTRUMENT. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN BECAUSE THE VALUES EXCEEDED THE SUM OF THE IGG SUBCLASS DETERMINATIONS. THE REPEAT TEST OF THE SAME SAMPLES ON AN ALTERNATE BNII INSTRUMENT GAVE LOWER RESULTS CONSISTENT WITH THE SUM OF THE SUBCLASSES. THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OF ADVERSE IMPACT TO THE PATIENTS DUE TO THE FALSELY ELEVATED IGG RESULTS, WHICH WERE NOT REPORTED TO THE PHYSICIAN.