MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-23 for ABBOTT M2000SP 09K14-01 manufactured by Abbott Molecular, Inc..
[3042233]
The abbott m2000 system is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the abbott m2000sp and the abbott m2000rt instruments. The abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. The abbott field service engineer found a broken liquid waste sensor window on the m2000sp instrument that is located in (b)(6). The engineer replaced the liquid waste sensor according to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10321882]
Abbott molecular has taken a field action ((b)(4)) to address this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2012-00016 |
| MDR Report Key | 2840234 |
| Report Source | 07 |
| Date Received | 2012-05-23 |
| Date of Report | 2012-04-25 |
| Date of Event | 2012-04-25 |
| Date Mfgr Received | 2012-04-25 |
| Date Added to Maude | 2012-12-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2123617274 |
| 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 |
| Removal Correction Number | FA-CAM-OCT2011-110 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT M2000SP |
| Product Code | JQW |
| Date Received | 2012-05-23 |
| Catalog Number | 09K14-01 |
| 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 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-23 |