APTIMA BV ASSAY
Received Jul 22, 2022 · Event occurred Jun 23, 2022
Report 2024800-2022-01070 · MDR key 15089973
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Hologic, Inc.Model number
BV ASSAY, APTIMA, 100T, IVDCatalog number
ASY-11550
Lot number
318661
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
Description of Event or Problem
ON (B)(6) 2022, A CUSTOMER REPORTED DISCREPANT RESULTS TO HOLOGIC FOR THE APTIMA BACTERIAL VAGINOSIS (BV) ASSAY FROM, PN ASY-11550 LOT NUMBER 318661. INITIAL RUN RESULTS INDICATE A NEGATIVE BV RESULT. RETEST RESULTS INDICATE A BV POSITIVE RESULT. PER CUSTOMER REQUEST, HOLOGIC REVIEWED THE LOGS AND NOTIFIED CUSTOMER OF POTENTIALLY AFFECTED SAMPLES. THE CUSTOMER RETESTED THE SAMPLES AND IDENTIFIED TWO SAMPLES THAT WERE DISCORDANT. THE CUSTOMER INDICATED THAT THEY CORRECTED THE REPORT FOR THESE SPECIMENS TO BV POSITIVE. THERE IS NO INDICATION THAT AN ADVERSE EVENT OCCURRED (THE PATIENT WAS IMPACTED) DUE TO THE INCORRECT RESULT. REVIEW OF CUSTOMER DATA BY HOLOGIC NOTED THAT PREVIOUS ABV RUNS HAD THE ¿CCE¿ FLAG, WHICH IS A CALIBRATION CHANNEL ERROR. PER AW-20220-001, REV. 001, THE PANTHER/PANTHER FUSION OPERATOR¿S MANUAL INDICATES TO CONTACT HOLOGIC TECHNICAL SUPPORT WHEN THEY RECEIVE THE ¿CCE¿ ERROR CODE. THE ISSUE WAS LIKELY CAUSED BY DEBRIS IN THE RTF. ROOT CAUSE INVESTIGATION IS IN PROCESS.
Description of Event or Problem
SEE H10.
Description of Event or Problem
FOLLOW-UP REPORT. SEE SECTION H10.
Additional Manufacturer Narrative
THE FOLLOWING IS A RESUBMISSION THAT WAS INITIALLY SUBMITTED AS A FOLLOW UP MDR (2024800-2022-01070) ON 08/31/2022 BY HOLOGIC. THE FIELD SERVICE ENGINEER (FSE) DURING SERVICING OF THE INSTRUMENT FOUND DEBRIS ON THE THIRD POSITION OF THE HEX RTF. THE FSE COULD NOT IDENTIFY WHERE THE DEBRIS ORIGINATED FROM AND HOW IT ENDED UP ON THE HEX RTF LENS. FSE DESCRIBED THE DEBRIS AS STICKY AND SPONGY AND DISCARDED IT DURING SERVICING. THE PROBABILITY OF HARM IS REMOTE AS THE DEBRIS APPEARED ON ONLY ONE OUT OF THE FIVE POSITIONS. OVER THE 2.5 MONTHS, ONLY ELEVEN SAMPLES WERE IDENTIFIED OF BEING IN POSITION 3 AND BEING READ BY THE COMPROMISED HEX RTF: 8 BV SAMPLES AND 3 QHBV SAMPLES. CUSTOMER RETESTED THESE 11 SAMPLES AND OBTAINED CONCORDANT RESULTS FOR THE 3 HBV SAMPLES. THUS, THERE IS NO RISK OF INCORRECT HBV RESULTS DUE TO THIS ISSUE. THE RESULTS OF TWO OF THE 8 BV RETESTED SAMPLES WERE DISCORDANT. THE CUSTOMER INDICATED THAT THEY CORRECTED THE REPORT FOR THESE SPECIMENS TO BV POSITIVE. THERE WAS NO INDICATION THAT AN ADVERSE EVENT OCCURRED DUE TO THESE INITIAL INCORRECT RESULTS.
Additional Manufacturer Narrative
SECTION B5 STATED "FOLLOW-UP REPORT. SEE SECTION H10." WHEN IT SHOULD HAVE REFERENCED SECTION H11.
Description of Event or Problem
SEE SECTION H11.