MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-09-15 for M2000SP 9K014-01 manufactured by Abbott Molecular, Inc..
[17397120]
The front hood panel of the m2000sp instrument has adhesive on the double-coated tape that was not strong enough to hold the window in place. Five internal instances have been documented. Additionally, five customer observations of the hood front window falling off have been documented. None of these individual instances have resulted in a medical device report (form 3500a). However, abbott molecular (am) took a field action in 2008. Thus abbott molecular is filing this mdr due to this situation's malfunction and abbott molecular's field correction.
Patient Sequence No: 1, Text Type: D, B5
[17638453]
Abbott molecular has identified a replacement tape to secure the front hood panel. A customer letter has been issued informing the customers that have a hood on their m2000sp system that a service call will be scheduled. If the customer suspects that the front hood panel is loose, then the m2000sp instrument is not to be used until the service visit is complete. Additional model #: 9k14-02.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2008-00002 |
| MDR Report Key | 1161496 |
| Report Source | 07 |
| Date Received | 2008-09-15 |
| Date of Report | 2008-09-12 |
| Date of Event | 2008-08-25 |
| Date Mfgr Received | 2008-08-25 |
| Date Added to Maude | 2009-08-06 |
| 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 | PAULA MARTIN, SENIOR MGR |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617333 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M2000SP |
| Generic Name | AUTOMATED SAMPLE PREPARATION SYSTEM |
| Product Code | KEY |
| Date Received | 2008-09-15 |
| Model Number | 9K014-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-15 |