PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY
Received Dec 30, 2024 · Event occurred Dec 4, 2024
Report 2024800-2024-00063 · MDR key 21044637
Device
Generic name
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2
Manufacturer
Hologic, Inc.Catalog number
ASY-16066
Lot number
CARTRIDGE LN 887495
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IN THE INITIAL RISK ASSESSMENT CONDUCTED BY HOLOGIC FOR THIS COMPLAINT, THE TERM ¿URGENCY WARD¿ WAS MISINTERPRETED AS BEING EQUIVALENT TO A ¿CRITICAL CARE UNIT¿. UPON ADDITIONAL REVIEW OF THE EVENT DETAILS, IT WAS CLARIFIED THAT ¿URGENCY WARD¿ IS EQUIVALENT TO ¿EMERGENCY ROOM¿ IN BELGIUM. FURTHERMORE, THERE WAS NO INDICATION THAT THE IMPACTED INDIVIDUAL WAS A TRANSPLANT PATIENT NOR IMMUNO-COMPROMISED. BASED ON THIS INFORMATION, THE RISK OF HARM WAS RE-ASSESSED APPROPRIATELY, AND THE PROBABILITY OF HARM FOR THIS SPECIFIC COMPLAINT WAS CONSIDERED ¿BROADLY ACCEPTABLE¿. AS A RESULT OF THIS DETERMINATION, HOLOGIC REMOVES EVENT CLASSIFICATION OF ¿SERIOUS¿ AND DEEMS THIS EVENT AS ¿NOT REPORTABLE¿.
Description of Event or Problem
FOLLOW-UP REPORT. SEE SECTION H11.
Additional Manufacturer Narrative
HOLOGIC REVIEWED THE SYSTEM LOGS PROVIDED BY THE CUSTOMER. LOGFILE REVIEW CONFIRMED THERE WERE NO SIGNS OF HARDWARE ISSUES WITH THE INSTRUMENT THAT COULD HAVE INTERFERED WITH THE RESULTS. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.
Description of Event or Problem
ON (B)(6) 2024, A CUSTOMER IN BELGIUM REPORTED TO HOLOGIC A POTENTIAL FALSE POSITIVE FOR SARS-COV-2 RESULT ON A SAMPLE TESTED WITH THE PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY (CARTRIDGE LN 887495) ON (B)(6) 2024. THERE WERE TWO SAMPLES TAKEN FROM THE SAME PATIENT FROM THE URGENCY WARD. THE FIRST SAMPLE (ID (B)(6)) GAVE A POSITIVE RESULT FOR SARS-COV-2 WITH HOLOGIC PANTHER INSTRUMENT (SN (B)(6)). THE CUSTOMER NOTED THAT THE INITIAL POSITIVE RESULT WAS REPORTED OUT TO THE PATIENT. THE SECOND SAMPLE (ID (B)(6)) WAS NEGATIVE FOR SARS-COV-2 WITH THE RESPIRATORY PANEL TESTED ON NON-HOLOGIC EQUIPMENT. THE SECOND SAMPLE WAS ALSO ANALYZED ON PANTHER (ON (B)(6) 2024) AND WAS FOUND TO BE NEGATIVE FOR SARS-COV-2. AFTERWARD, THE FIRST SAMPLE WAS REPEATED ON BOTH PANTHER AND NON-HOLOGIC EQUIPMENT, BOTH RESULTS WERE FOUND TO BE SARS-COV-2 NEGATIVE. THE CUSTOMER NOTED THAT AFTER THE CONFIRMATION TESTING, THE RESULT WAS AMENDED TO NEGATIVE. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.