APTIMA COMBO 2 ASSAY
Received Oct 1, 2024 · Event occurred Sep 3, 2024
Report 2024800-2024-00017 · MDR key 20344844
Device
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
HOLOGIC REVIEWED LOGS PROVIDED BY THE CUSTOMER. HOLOGIC DID NOT IDENTIFY ANY HARDWARE OR REAGENT PREPARATION ISSUES AND DETERMINED THAT THE SAMPLE WAS EITHER MISHANDLED OR HAD A LOW TARGET CONCENTRATION. HOLOGIC TECHNICAL SUPPORT RELAYED THE LOG REVIEW TO THE CUSTOMER AND ADVISED TO OPERATE THE INSTRUMENT ACCORDING TO THE PANTHER OPERATOR¿S MANUAL AND TO PREPARE SAMPLES AND REAGENTS ACCORDING TO THE INSTRUCTIONS IN THE APTIMA COMBO 2 ASSAY PACKAGE INSERT.
Description of Event or Problem
ON (B)(6) 2024, A CUSTOMER REPORTED TO HOLOGIC THAT THEY OBTAINED A DISCREPANT GC RESULT USING THE APTIMA COMBO 2 ASSAY, MASTER LOT 899831. THE SPECIMEN WAS INITIALLY TESTED ON (B)(6) 2024 AND RESULTED GC POSITIVE. THE SAMPLE WAS RETESTED ON (B)(6) 2024, AND AGAIN ON (B)(6) 2024, AND RESULTED AS GC NEGATIVE BOTH TIMES. THE RESULT WAS AMENDED BUT THE CUSTOMER CONFIRMED THAT PATIENT TREATMENT WAS PROVIDED BASED ON THE INITIAL POSITIVE RESULT.