inforMED
InjuryQOF

HOLOGIC RESPDIRECT COLLECTION KIT; PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY

Received Jan 13, 2025 · Event occurred Dec 14, 2024

Report 2024800-2025-00003 · MDR key 21137774

Device

Generic name

Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2

Manufacturer

Hologic, Inc.

Model number

ASY-16066

Lot number

887495

Product problems

  • Imprecise or Erratic Results
  • Device Contaminated at the User Facility
  • Imprecise or Erratic Results
  • Device Contaminated at the User Facility

Patient

NA · Unknown

  • Insufficient Information
  • No Clinical Signs, Symptoms or Conditions
  • Insufficient Information
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ON DECEMBER 16, 2024, CUSTOMER RELAYED TO HOLOGIC THAT THEY HAD SAMPLE ID (B)(6) RESULT AS SARS-COV-2 AND RSV POSITIVE WITH OUR FUSION SARS-COV-2/FLU A/B/RSV ASSAY (CARTRIDGE LOT 887495) ON THEIR PANTHER FUSION (SN (B)(6)) UNDER WORKLIST ID (B)(6) WHERE THE SAME SAMPLE REPEATED AS ONLY RSV POSITIVE WHEN RETESTED ON THE PANTHER FUSION UNDER THE SAME WORKLIST ID. SAMPLE ALSO RETESTED AS ONLY RSV POSITIVE WHEN REPEATED ON THE GENEXPERT PLATFORM. THE SAMPLE WAS STORED AT AMBIENT TEMPERATURE BEFORE THE TEST, AND STORED AT +2 TO +8°C AFTER THE TEST. ANALYSIS OF THE SAMPLE CURVE DATA FOUND NO SAMPLE HANDLING ISSUES WITH NORMAL AMPLIFICATION. CUSTOMER PERFORMED RETESTING DUE TO IT BEING A DUAL POSITIVE. THE DUAL POSITIVE RESULT WAS AUTOMATICALLY REPORTED OUT BEFORE BEING AMENDED TO BEING ONLY RSV POSITIVE. THE SAMPLE WAS FROM THE EMERGENCY/URGENT CARE WARD. INFORMATION ABOUT ANY TREATMENT PERFORMED IS UNKNOWN AND CASE TROUBLESHOOTING IS ONGOING AT THIS TIME.

Description of Event or Problem

ON DECEMBER 16, 2024, CUSTOMER RELAYED TO HOLOGIC THAT THEY HAD SAMPLE ID (B)(6) RESULT AS SARS-COV-2 AND RSV POSITIVE WITH OUR FUSION SARS-COV-2/FLU A/B/RSV ASSAY (CARTRIDGE LOT 887495) ON THEIR PANTHER FUSION (SN (B)(6)) UNDER WORKLIST ID (B)(6) WHERE THE SAME SAMPLE REPEATED AS ONLY RSV POSITIVE WHEN RETESTED ON THE PANTHER FUSION UNDER THE SAME WORKLIST ID. THE DUAL POSITIVE RESULT WAS AUTOMATICALLY REPORTED OUT BEFORE BEING AMENDED TO BEING ONLY RSV POSITIVE. THE SAMPLE WAS FROM THE EMERGENCY/URGENT CARE WARD. INFORMATION ABOUT ANY TREATMENT PERFORMED IS UNKNOWN AND CASE TROUBLESHOOTING IS ONGOING AT THIS TIME.

Description of Event or Problem

FOLLOW-UP REPORT. SEE SECTION H11.

Additional Manufacturer Narrative

ADDITIONAL FOLLOW-UP AND TROUBLESHOOTING WITH CUSTOMER FOUND THEY WERE EXPERIENCING A CONTAMINATION EVENT THAT HAS SINCE BEEN RESOLVED. ANY PATIENT TREATMENT STILL REMAINS UNKNOWN.

Description of Event or Problem

FOLLOW-UP REPORT CORRECTING IMDRF CODES NOW THAT ADDITIONAL INFORMATION IS AVAILABLE.