APTIMA SARS COV-2
Received Jul 21, 2022 · Event occurred Jun 23, 2022
Report 2024800-2022-01068 · MDR key 15080169
Device
Generic name
Reagents, 2019-novel Coronavirus Nucleic Acid
Manufacturer
Hologic, Inc.Catalog number
PRD-06419
Lot number
319624
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2022, CUSTOMER REPORTED THAT THEY WERE STILL EXPERIENCING POSITIVE CONTAMINATION AFTER HOLOGIC SERVICED THE CUSTOMER¿S PANTHER INSTRUMENT SN (B)(4) ON (B)(6) 2022. BECAUSE CUSTOMER SUSPECTED THAT THERE WAS STILL CONTAMINATION, CUSTOMER DISCONTINUED THE USE OF THE INSTRUMENT AND DECIDED TO PERFORM ADDITIONAL INVESTIGATIONAL TESTING. CUSTOMER THEN ASKED HOLOGIC TO REVIEW LOGS FOR WORKLIST 003331-20220615-07. CUSTOMER USED ASSAY LOT 319624. THE WORKLIST CONTAINS 168 SAMPLES TESTED AND 39 WERE POSITIVE. HOLOGIC FIELD SERVICE ENGINEERS (FSE) WENT TO THE CUSTOMER SITE, PERFORMED A FULL PERFORMANCE QUALIFICATION (PQ) ON PANTHER INSTRUMENT SN (B)(4) AND PRODUCED THE EXPECTED RESULTS. HOLOGIC CONCLUDED THAT THE DISCREPANT RESULTS MAY HAVE POTENTIALLY BEEN DUE TO SAMPLE MISHANDLING, CROSS CONTAMINATION, THE PRESENCE OF A LOW TARGET, OR TARGET DEGRADATION DUE TO HANDLING AND STORAGE. FSE REPORTED THAT THE CUSTOMER FEELS CONFIDENT THAT THE MULTIPLE CLEANINGS HAVE RESOLVED THE ISSUE AND HAS CONTINUED USING THE PANTHER INSTRUMENT. NO PRODUCT IMPACT IS KNOWN TO DATE. A REVIEW OF THE LOGS DID NOT REVEAL INSTRUMENT ISSUES.