MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for VYSIS LSI IGH/CCND1 XT DUAL COLOR DUAL FUSION PROBES 05J72-001 manufactured by Abbott Molecular, Inc..
[126222267]
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 Sequence No: 1, Text Type: N, H10
[126222268]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00015 |
| MDR Report Key | 7986615 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-10-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOE HUTSON |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617619 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VYSIS LSI IGH/CCND1 XT DUAL COLOR DUAL FUSION PROBES |
| Generic Name | REAGENTS, SPECIFIC, ANALYTE |
| Product Code | MVU |
| Date Received | 2018-10-19 |
| Catalog Number | 05J72-001 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |