CONFIRM ER
Received May 25, 2017 · Event occurred Jan 19, 2017
Report 2028492-2017-00002 · MDR key 6592947
Device
Generic name
Confirm Er
Manufacturer
Ventana Medical Systems IncModel number
05278406001Catalog number
790-4324
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- Misdiagnosis
- No Known Impact Or Consequence To Patient
- Misdiagnosis
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT IS UNKNOWN IF THERE IS A DETERIORATION IN PATIENT HEALTH. WE HAVE ASKED THE CUSTOMER MULTIPLE TIMES WITH NO RESPONSE. INVESTIGATION STATEMENT AND CONCLUSION: THERE IS NO INDICATION OF A MALFUNCTION OF VENTANA MEDICAL SYSTEM'S INSTRUMENT OR ASSAY. NO CORRECTIONS TAKEN BY THE MANUFACTURER SINCE NO VENTANA PRODUCT MALFUNCTION IDENTIFIED. HOWEVER INFORMATION WAS PROVIDED TO THE CUSTOMER ON THE "IMPACT OF ENVIRONMENTAL STRESS ON VARIOUS HISTOLOGY SLIDE TYPES". THE CUSTOMER HAS NOW CHANGED FROM HISTOBOND SLIDES TO ANOTHER SLIDE MANUFACTURER (TOMO SLIDES FROM MATSUNAMI). THEY HAVE REPORTED NO ISSUES SINCE SWITCHING SLIDE TYPES. THIS IS AN INITIAL AND FINAL REPORT.
Description of Event or Problem
CUSTOMER USED A SAME SLIDE POSITIVE CONTROL TISSUE SECTION WHICH STAINED POSITIVE. PATIENT SAMPLE WAS NEGATIVE AND ACCORDINGLY PATIENT WAS DIAGNOSED TRIPLE NEGATIVE (ER, PR, HER2). SIX WEEKS LATER, THE PATIENT SAMPLE WAS RE-STAINED IN ANOTHER HOSPITAL AND FOUND TO BE ER-POSITIVE. THEY ASSUMED THE REASON FOR THE FAILED STAINING IN THE FIRST RUN WAS THE SLIDE SURFACE PROPERTIES ON THE SLIDES THEY USED. THE CUSTOMER HAS NOW CHANGED FROM HISTOBOND SLIDES TO ANOTHER SLIDE MANUFACTURER (TOMO SLIDES FROM MATSUNAMI).