FDA Adverse Event Malfunction Summary report: N

HOLOGIC DIMENSIONS

MDR report key: 19468676 · Received June 4, 2024

Report

Report Number
MW5155747
Event Type
Malfunction
Date Received
June 4, 2024
Date of Event
May 3, 2024
Report Date
May 30, 2024
Manufacturer
HOLOGIC, INC.
Product Code
MUE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
OTHER
Health Professional
*

Narratives

Description of Event or Problem · 0

PATIENT CAME TO A MOBILE MAMMOGRAPHY UNIT FOR A SCREENING MAMMOGRAM. SHE FILLED OUT THE INTAKE FORM AND THE MAMMOGRAM WAS BEGUN. AFTER THE FIRST IMAGE, THE TECHNOLOGIST (VERY EXPERIENCED AND EXCELLENT) NOTED THAT THE PATIENT HAD IMPLANTS THAT SHE HAD NOT INDICATED ON THE FORM, SO SHE THEN CLICKED TO INDICATE THE PRESENCE OF IMPLANTS AND CONTINUED ON WITH THE EXAM. AT SOME POINT, AN ALERT POPPED UP AND SHE (WITHOUT READING IT SHE SAYS), CLICKED OK. LATER WHEN THE VAN RETURNED TO HOME BASE, SHE NOTED THAT THE PATIENT WAS NO LONGER ON THE PATIENT LIST AND SHE COULD NOT FIND THE IMAGES. HOLOGIC AND OUR IT DEPARTMENT HAVE ALSO FAILED TO FIND THE IMAGES. THAT IS, THEY ARE NOT IN ANY "TRASH BIN" BUT RATHER ALL INFORMATION ABOUT THIS PATIENT HAS BEEN DESTROYED. THE PATIENT MUST HAVE THE EXAM REPEATED. WE SUGGEST THAT DELETION OF A LIVE RECORD THAT HAS NOT BEEN TRANSFERRED TO AN EXTERNAL ARCHIVE SHOULD BE AN INTENTIONAL PROCESS REQUIRING RE-ENTRY OF A PASSWORD AS DURABLE ATTESTATION THAT YOU'RE DOUBLY SURE RATHER THAN A SINGLE CLICK. WE ALSO REQUEST THAT ONE IN A MANAGER ROLE BE REQUIRED TO DELETE AND THAT ONE IN A MANAGER ROLE NOT BE ALLOWED TO ACQUIRE IMAGES IN THE MANAGER ROLE, BUT HAVE 2 DISTINCT ROLES: TECHNOLOGIST AND MANAGER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1150113 HOLOGIC DIMENSIONS FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC MUE HOLOGIC, INC.

Patients

Seq Age Sex Outcome Treatment
1 52 YR Female Other BREAST IMPLANTS.