CLINITEK ADVANTUS
Received Feb 3, 2021 · Event occurred Dec 10, 2020
Report 3002637618-2021-00005 · MDR key 11273150
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION: INVESTIGATIONAL TESTING WAS PERFORMED ON RETURNED LOT #004075 (EXP 10/31/2021) USING THREE TECHNICAL OPERATIONS OWNED CLINITEK ADVANTUS INSTRUMENTS (S/N (B)(6)). TESTING WAS COMPLETED USING A WBC NEGATIVE SOLUTION (LOT # JGF020321 EXP 2/3/22) AND A WBC POSITIVE 42 CELLS/UL SOLUTION (PIWI-00464-MSH LOT # 0063-05 EXP 6/3/21). FOUR RESULTS WERE OBTAINED PER INSTRUMENT WITH BOTH THE WBC POSITIVE AND WBC NEGATIVE SOLUTIONS. RESULTS: NO FALSE NEGATIVE RESULTS WERE REPORTED. BASED ON THE DATA COLLECTED, THE CUSTOMER REPORT OF FALSE NEGATIVE WBC PERFORMANCE FROM N-MULTISTIX SG-L LOT #004075, AS REPORTED IN GSMS PM00264070 WAS NOT OBSERVED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED ANY REMAINING REAGENT TO BE SENT BACK FOR INVESTIGATION. THE CUSTOMER HAS REQUESTED POSSIBLE CAUSES FOR FALSE NEGATIVE LEUCOCYTES WHICH HAVE BEEN PROVIDED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE NEGATIVE LEUKOCYTE RESULT ON THE CLINITEK ADVANTUS WHEN COMPARED TO THE MICROSCOPIC SEDIMENT AND A NON-SIEMENS CHEMISTRY ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.