MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-27 for VP 2000 PROCESSOR 02J11 (30-144101) manufactured by Abbott Molecular, Inc.
[1431030]
The abbott vp 2000 processor is a device designed to automate and standardize slide specimen processing and routine slide staining for the laboratory. Customer reported having a leaking basin after receiving the product recall notification for potential vp 2000 processor leaking basins. The notification asked from customers to take the following action: "if you notice leaking or warped basins or an inability to place the basins into the vp 2000 processor, please call your local abbott molecular representative for coordination of basin replacement. An abbott molecular customer service representative or field service representative will be calling you to coordinate replacement of your vp 2000 heated reagent basins before december 31, 2010. Please note that additional measures have been taken to ensure currently available inventory does not exhibit this issue. " abbott molecular distributed an urgent product recall (3005248192-06/18/2010-001-c) via (b)(4) to (b)(6) customers based on customer receipt of vp 2000 processor and basin spare part since (b)(6) 2008. The following mdrs were also filed: mdr 3005248192-2010-0002, filed on (b)(4). Mdr 3005248192-2010-0005, filed on (b)(4). Mdr 3005248192-2010-0006, (b)(4). Mdr 3005248192-2010-0007, filed on (b)(4). No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8763913]
Abbott molecular inc. Is aware of the problem with the vp 2000 processor basins. An urgent product recall (3005248192-06/18/2010-001-c) was distributed via (b)(4) to (b)(6) customers based on customer receipt of vp 2000 processor and basin spare part since (b)(4) 2008. The following mdrs were also filed: mdr 3005248192-2010-0002, filed on (b)(4). Mdr 3005248192-2010-0005, filed on (b)(4). Mdr 3005248192-2010-0006, filed on (b)(4). Mdr 3005248192-2010-0007, filed on (b)(4). Three potential hazards were identified: delay in results. There is no harm associated with this hazard. Chemical exposure. There is no harm associated with this hazard as this issue does not increase the already expected exposure to these reagents. Therefore, there is no introduced operator harm. Slip hazard. Evaluation determined that the overall health risk was low, based on the following: the overall estimate for a leaking basin was (b)(4) (based on basins known to be related to this issue). (b)(4). When a loaded basin is either used in the vp2000 or stored on the lab bench, in the typical usage time < 8 hours), the leaked liquid will be less than 50 ml. Slip hazard will be avoided by the operator's observance of the liquid on the floor and by the small volume of liquid. If a leak were to occur, it would occur in an area that a lab operator would not normally walk (in the vp2000) or during reagent addition (lab bench). In addition, the leak would be visually obvious to the operator. If the operator did step on the leak, it would not necessarily lead to a fall that would lead to a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2010-00008 |
| MDR Report Key | 1845150 |
| Report Source | 07 |
| Date Received | 2010-09-27 |
| Date of Report | 2010-08-09 |
| Date of Event | 2010-08-09 |
| Date Mfgr Received | 2010-08-09 |
| Date Added to Maude | 2012-01-09 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAMELA SWATKOWSKI |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617013 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VP 2000 PROCESSOR |
| Generic Name | STAINER, TISSUE, AUTOMATED |
| Product Code | KEY |
| Date Received | 2010-09-27 |
| Catalog Number | 02J11 (30-144101) |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-27 |