MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-29 for ABBOTT M2000RT 09K15-01 manufactured by Abbott Molecular, Inc..
[2864933]
The abbott m2000 system is intended for use in performing nucleic acid testing in clinical labs. 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 m2000rt is an automated system for performing fluorescence-based pcr to provide quantitive and qualitative detection of nucleic acid sequences. A customer in (b)(6) reported that there was a paper jam error on the m2000rt during printing. When the customer tried to clear the jam, he observed that the last papers looked and smelled burnt. The customer indicated the papers looked discolored and there was no visible fire or smoke. There was no injury caused by this issue.
Patient Sequence No: 1, Text Type: D, B5
[10223051]
Abbott molecular has requested the return of the printer for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2011-00023 |
| MDR Report Key | 2698806 |
| Report Source | 07 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-11-02 |
| Date Mfgr Received | 2011-11-02 |
| Date Added to Maude | 2012-08-20 |
| 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 | MR DIMITRIS DEMIRTZOGLOU |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617975 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| 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 | 2011-11-29 |
| Catalog Number | 09K15-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-29 |