| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VYSIS LSI IGH/CCND1 XT DUAL COLOR DUAL FUSION PROBES | REAGENTS, SPECIFIC, ANALYTE | ABBOTT MOLECULAR, INC. | MVU | 05J72-001 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-19 | 0 |
Patient 1
COMPLAINT INVESTIGATION HAS BEEN INITIATED. NOTE: LOT, EXPIRATION, UDI, MANUFACTURE DATE AND PMA NUMBER HAVE BEEN LEFT BLANK AS THIS MDR IS BEING SUBMITTED ON THE BASIS THAT VYSIS IGH/CCND1 XT DF FISH PROBE KIT, LIST NUMBER 05N33-20 IS SIMILAR TO US FDA APPROVED ANALYTE SPECIFIC REAGENT, VYSIS LSI IGH/CCND1 XT DUAL COLOR DUAL FUSION PROBES, LIST NUMBER 05J72-001. TICKET DOES NOT REFERENCE A US LIST 05J72-001 LOT NUMBER.
Patient 1
THE CUSTOMER RECEIVED 1 VYSIS IGH/CCND1 XT DF FISH PROBE KIT (05N33-20) IN THEIR SHIPMENT THAT IS DAMAGED. THE KIT IN QUESTION WAS FOUND ON DRY ICE IN THE STYROFOAM BOX, AND THE CUSTOMER STATED THE KIT WAS NOT SEPARATED BY THE CARDBOARD THAT THEY USUALLY RECEIVE ITEMS IN. THE VYSIS PROBE VIAL AND THE HYBRIDIZATION BUFFER TUBES IN THE PACK ARE DAMAGED WHERE THE SKIRTING OF THE TUBE WAS SHATTERED. THE CONTENT OF THE REAGENT WAS NOT AFFECTED, AND NO LEAKAGE WAS OBSERVED. LABELS OF BOTH OF THE TUBES HAD FALLEN OFF. THE EXTERIOR OF THE STYROFOAM WAS NOT DAMAGED. SINCE THE BROKEN BOTTLES WERE FOUND STILL INSIDE THE VYSIS PROBE BOX, MOLECULAR APPLICATION SPECIALIST CONFIRMED WITH THE CUSTOMER THAT THEY WERE NOT INJURED BY THE BROKEN BOTTLES. A REPLACEMENT KIT WAS DELIVERED TO THE CUSTOMER. THIS MEDICAL DEVICE REPORT (MDR) IS SUBMITTED ON THE BASIS THAT IF THIS OBSERVATION WAS CAUSED BY AN ABBOT PRODUCT MALFUNCTION AND THAT MALFUNCTION WERE TO RECUR, A SHATTERED TUBE SKIRT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. NO PATIENT WAS INVOLVED. THE OBSERVATION WAS MADE BY THE INDIVIDUAL UNPACKING THE REAGENT ORDER. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) WHEN RECEIVING VYSIS IGH/CCND1 XT DF FISH PROBE KIT, LIST NUMBER 05N33-20, WHICH IS SIMILAR TO US FDA APPROVED ANALYTE SPECIFIC REAGENT, VYSIS LSI IGH/CCND1 XT DUAL COLOR DUAL FUSION PROBES, LIST NUMBER 05J72-001.