| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HERCEPTEST FOR AUTOMATED LINK PLATFORMS | HERCEPTEST FOR AUTOMATED LINK PLATFORMS | DAKO DENMARK A/S | MVC | SK001 | 20026157 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-06-13 | 0 | 1. O |
Patient 1
AS PART OF DAKO'S INTERNAL AUDIT AND CONTINUOUS IMPROVEMENT PROCESS, DAKO PERFORMED AN INTERNAL REVIEW OF COMPLAINTS BEGINNING WITH THOSE INITIATED (B)(6) 2015. THIS REPORT IS BASED ON THAT REVIEW AS COMPLAINT (B)(4) WAS DETERMINED TO BE MDR REPORTABLE. IT IS THEREFORE BEING FILED WITH THE FDA RETROSPECTIVELY. THIS IS AN INITIAL AND FINAL REPORT COMBINED. THE INVESTIGATION FOR THIS CASE WAS CLOSED IN 2015, BUT IT HAS BEEN REOPENED AND REASSESSED AS PART OF THE INTERNAL REVIEW.
Patient 1
DEVICE INVOLVED IN THIS COMPLAINT: SK001, HERCEPTEST (RUN ON AUTOSTAINER LINK 48 INSTRUMENT). SUMMARY: INCONSISTENT STAINING ON THE SK001 HERCEPTEST ASSAY, RUN ON THE AUTOSTAINER LINK 48 INSTRUMENT (AS48), RESULTED IN A FALSE NEGATIVE RESULT. THE CUSTOMER RERAN THE PATIENT TISSUE USING A VENTANA ASSAY, WHICH RESULTED IN A STRONG POSITIVE, WHICH WAS SUBSEQUENTLY CONFIRMED AS POSITIVE WITH FISH TESTING. THERE WAS NO PATIENT HARM AS THE CUSTOMER COMPLETED THE TESTS WITHIN A CLINICALLY INSIGNIFICANT TIME FRAME AND THE ISSUE WAS RESOLVED WITHOUT MISDIAGNOSIS. ASSESSMENT: A FALSE NEGATIVE TEST RESULT WAS OBTAINED WITH PRODUCT SK001, HERCEPTEST FOR AUTOMATED LINK PLATFORMS, LOT NO. 20026157. THE CUSTOMER OBSERVED WEAK STAINING ON THE PATIENT TISSUE AND RETESTED THE TISSUE WITH A COMPETITOR, VENTANA, ASSAY. AS THE VENTANA ASSAY TESTED POSITIVE, THE CUSTOMER SENT THE TISSUE FOR FISH TESTING WHICH INDICATED THE TISSUE WAS POSITIVE, HER2 GENE AMPLIFIED. INVESTIGATION RESULTS: A COMPLAINT REVIEW OF THE ASSAY LOT NUMBER WAS PERFORMED AND NO OTHER COMPLAINTS WERE LOGGED ON THIS SK001 ASSAY LOT NUMBER. INFORMATION WAS PROVIDED THAT THE LABORATORY ONLY RUNS GASTRIC TISSUE AS A CONTROL. THE LABORATORY WAS ASKED TO PROVIDE INFORMATION ABOUT THE CELL CONTROL LINE (CCL), WHICH IS INCLUDED IN THE KIT AS A RUN CONTROL, AND THE IN-HOUSE CONTROL TISSUE, HOWEVER, THESE WERE NOT PROVIDED. IN ADDITION, THE INSTRUMENT SERIAL NUMBER(S) WERE NOT OBTAINED. IT WAS NOTED THAT THE PREVIOUS AS48 PREVENTIVE MAINTENANCE WAS IN 2013. THE CAUSE OF THE PRODUCT MALFUNCTION WAS NOT IDENTIFIED BUT PRESUMED TO BE CAUSED BY AN UNEVEN SLIDE RACK, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL FAILURE MODE. AS AN UNEVEN SLIDE RACK WAS DETERMINED TO BE THE MOST LIKELY CAUSE, NEW SLIDE RACKS WERE SENT TO THE CUSTOMER. NO OTHER ISSUES WERE RAISED BY THE CUSTOMER AT THAT TIME AND THE NEW SLIDE RACK WAS PRESUMED TO HAVE RESOLVED THE ISSUE. THIS COMPLAINT HAS BEEN ASSOCIATED WITH CAPA (B)(4) (SLIDE RACKS) WHICH WAS RECENTLY INITIATED FOR THIS FAILURE MODE.