N LATEX ADNASE B
Received Oct 8, 2012 · Event occurred Sep 6, 2012
Report 9610806-2012-00014 · MDR key 2775448
Device
Generic name
N Latex Adnase B
Manufacturer
Siemens Healthcare Diagnostics Products GmbhCatalog number
OWTI
Lot number
41601
Product problems
- Low Test Results
Patient
7 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A FALSELY DEPRESSED ANTI-STREPTOCOCCAL DNASE B (ADNASE B) RESULT WAS REPORTED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS RE-RUN AND A HIGHER RESULT WAS OBTAINED IN LINE WITH PHYSICIAN EXPECTATIONS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED ADNASE B RESULT. THERE IS NO REPORT OF ADVERSE OUTCOME TO PATIENTS AS A RESULT OF FALSELY DEPRESSED ADNASE B RESULT.
Additional Manufacturer Narrative
THE CAUSE OF THE FALSELY DEPRESSED ADNASE B RESULT WAS SAMPLE INTEGRITY. THE N LATEX ADNASE B IFU STATES: SERUM SAMPLES MUST BE COMPLETELY COAGULATED AND, AFTER CENTRIFUGATION, MUST NOT CONTAIN ANY PARTICLES OR TRACES OF FIBRIN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.