MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-01 for ABBOTT M2000RT 09K15-01 manufactured by Abbott Molecular, Inc..
[21358439]
A technical review by a product support engineer determined that the m 2000rt block drive assembly failure was caused by electrical arcing or a short circuit. The overheating was due to the thermal degradation of the electrical component and associated insulation which caused a small amount of blackening or soot marks.
Patient Sequence No: 1, Text Type: N, H10
[21459906]
The abbott m2000rt is part of the m2000 realtime system and is for real-time pcr amplification and detection of nucleic acids. A customer in (b)(6), reported an error code display during initialization of the m2000rt instrument. The abbott field service engineer visited the customer site as a follow up to the customer report and observed a charred mark and some damaged components on the block drive assembly interface. The fse replaced the block drive assembly. There was no injury caused by this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2012-00015 |
| MDR Report Key | 2840231 |
| Report Source | 07 |
| Date Received | 2012-05-01 |
| Date of Report | 2012-04-02 |
| Date of Event | 2012-03-27 |
| Date Mfgr Received | 2012-04-02 |
| 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 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT M2000RT |
| Generic Name | REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM |
| Product Code | OOI |
| Date Received | 2012-05-01 |
| Catalog Number | 09K15-01 |
| 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 | 2012-05-01 |