FDA Adverse Event Malfunction Summary report: N

TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

MDR report key: 21422027 · Received February 20, 2025

Report

Report Number
MW5166539
Event Type
Malfunction
Date Received
February 20, 2025
Date of Event
February 7, 2025
Report Date
February 14, 2025
Manufacturer
LABCORP GENETICS
Product Code
JKA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2025 I HAD DR. (B)(6), DO OF (B)(6) PERFORM A COLPOSCOPY AND COLLECT FOUR SAMPLES TO SEND TO THE PATHOLOGIST AT (B)(6). THE FOLLOWING WEEK ON TUESDAY (B)(6) 2025 I RECEIVED MY RESULTS IN AN EMAIL FROM (B)(6) AND GOT A CALL FROM DR. (B)(6) ON WEDNESDAY 02/12/25 SAYING MY RESULTS WERE FINE/CLEAR. WHEN I HAD ASKED ABOUT WHY WOULD MY PAP BE FLAGGED IN THE FIRST PLACE TO REQUIRE FURTHER TESTING (COLPOSCOPY) AND ASKED ABOUT HOW COMMON IT IS TO GET A COMPLETELY CLEAN FALSE POSITIVE LIKE THAT, SHE HAD MADE A COMMENT ABOUT HER WORRY OR CONCERN THE PATHOLOGIST IS NOT AS CLEAN AS THEY SHOULD BE AND MADE ANOTHER COMMENT ALONG THE LINES OF THIS TYPE OF FALSE POSITIVE SITUATION HAPPENING MORE OFTEN THAN WHAT IS CONSIDERED NORMAL WITH THE PATHOLOGIST THEY SEND SAMPLES TO. IT IS BECAUSE OF THIS EXPERIENCE AND THOSE COMMENTS THAT I AM REQUESTING AN INVESTIGATION INTO (B)(6) AND (B)(6) TO IDENTIFY IF SOME CLEANLINESS/ CONTAMINATION ISSUES EXIST AND IF THERE IS A LARGER NUMBER OF FALSE POSITIVES HAPPENING BETWEEN THESE TWO FACILITIES, ETC. THE "PERFORMING" (B)(6) ON THE REPORT WERE (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1044776 TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA LABCORP GENETICS

Patients

Seq Age Sex Outcome Treatment
1 37 YR Female