VIDAS CMV IGG
Received Jul 24, 2020
Report 8020790-2020-00061 · MDR key 10322963
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE WHO OBTAINED AN INVALID CMV IGG RESULTS WHEN TESTING A PATIENT SAMPLE USING VIDAS® CMV IGG TEST KIT (REF. (B)(4); LOT 1007624880). A VIDAS SYSTEM MESSAGE INDICATED THAT THE SAMPLE MIGHT BE OVER-DILUTED ON A CMV TEST (CMVV AVIDITY AND/OR CMV IGG), AND YET THE SAMPLE WAS UNDILUTED. AN INVESTIGATION WAS CONDUCTED WHICH INCLUDED A REVIEW OF THE FULL SYSTEM BACKUP DATA SENT FROM THE CUSTOMER, NOTHING ABNORMAL WAS DETECTED. BIOMERIEUX INVESTIGATORS ALSO CONDUCTED NUMEROUS TESTS IN AN ATTEMPT TO REPLICATE THE ERROR MESSAGE HOWEVER THE ISSUE COULD NOT BE REPRODUCED INTERNALLY. DATA REVIEW FROM ASSOCIATED COMPLAINTS INDICATED THAT THIS ANOMALY OCCURRED RANDOMLY FOR VIDAS 3 INSTRUMENTS USING SOFTWARE VERSIONS 1.3. THE RISK ASSOCIATED WITH THIS ERROR MESSAGE WAS ASSESSED AND FOUND TO BE MINOR. AS A RESULT OF THIS ERROR MESSAGE, NO RESULT IS RELEASED THEREFORE THERE IS NO RISK OF OBTAINING AN INCORRECT RESULT. DESPITE THE FACT THAT THE ROOT CAUSE HAS NOT BEEN IDENTIFIED, BIOMERIEUX PLANS TO ADD ADDITIONAL LOGS INTO THE VIDAS 3 SOFTWARE VERSION 1.4 TO CAPTURE INTERACTIONS BETWEEN THE VIDAS 3 SOFTWARE AND THE COMPUTATION ENGINE. ADDITIONALLY, A WORKAROUND WILL BE DEVELOPED IN THE EVENT THAT THE ERROR MESSAGE IS DISPLAYED FOR AN UNDILUTED SAMPLE. SEE SECTION H10.
Description of Event or Problem
A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING AN INVALID RESULT WHEN TESTING A PATIENT SAMPLE WITH THE VIDAS¿ (B)(6) IGG 60 TESTS (REF 30204, LOT 1007624880). THE CUSTOMER REPORTED OBTAINING A SUSPECTED FALSE (B)(6) RESULT WHEN TESTING THE PATIENT SAMPLE WITH ANOTHER METHOD (DIASORIN). THE CUSTOMER THEN PERFORMED TESTING WITH THE VIDAS¿ (B)(6) IGG 60 TESTS (REF 30204, LOT 1007624880) AND OBTAINED AN INVALID RESULT. THE CUSTOMER INDICATED THAT AT THE TIME OF THE INVALID RESULT, THEY WOULD NOT BE ABLE TO REPORT RESULTS TO THE PHYSICIAN AND RESULTS WOULD BE DELAYED UNTIL A SOLUTION WAS IDENTIFIED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS DELAY LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. REF 30204 IS NOT REGISTERED WITH THE FDA FOR USE IN THE UNITED STATES. ACCORDING TO TRACKIT, THE REGISTRATION STATUS FOR REF 30204 IS "ON HOLD." HOWEVER, A SIMILAR PRODUCT, REF 30204-01, IS REGISTERED WITH THE FDA FOR USE IN THE UNITED STATES (K920661).