MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-17 for ABBOTT M2000SP INSTRUMENT 09K14-02 manufactured by Abbott Molecular, Inc..
[114706320]
An elevated complaint investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[114706321]
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 m2000rt is an automated system for performing fluorescence-based pcr to provide quantitative and qualitative detection of nucleic acid sequences. Customer reported that their m2000sp instrument remained offline. A field service engineer went on site and found evidence of overheating/charring on the pcba (printed circuit board assembly). Elevated complaint investigation has been opened. No patient was involved. The observation was made by an abbott molecular field service engineer. This incident is being reported to fda because the incident occurred in (b)(6) using the m2000sp instrument, list number 09k14-02 which is also approved for use in the united states.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00007 |
| MDR Report Key | 7696598 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-17 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2015-07-13 |
| Date Added to Maude | 2018-07-17 |
| 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 | 3 |
| Brand Name | ABBOTT M2000SP INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | JJH |
| Date Received | 2018-07-17 |
| Model Number | 09K14-02 |
| Catalog Number | 09K14-02 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-07-17 |