MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-06-05 for M2000SP INSTRUMENT 09K14-01 manufactured by Abbott Molecular, Inc..
[846822]
A customer had cut her finger on the waste chute (diti slide) during daily maintenance while she was drying the waste chute around the cut away section near the bottom of the chute. The operator was wearing gloves at the time. The glove was torn and the customer experienced an open cut on the finger. This injury carries a risk of potential biohazardous exposure.
Patient Sequence No: 1, Text Type: D, B5
[8086369]
At this point, a customer letter is being written to alert customers to not put their hands inside the waste chute. Secondly, the waste chute fabrication will include all edges to be broken with a 0. 2 mm cut at a 45 degree angle. Even though the material specification does include this 45 degree angle, these waste chutes were not fabricated to the edging specification. New waste chutes will be provided to the customers once this fabrication has been actually implemented in the waste chute production.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2008-00001 |
| MDR Report Key | 1057662 |
| Report Source | 07 |
| Date Received | 2008-06-05 |
| Date of Report | 2008-06-03 |
| Date of Event | 2008-05-08 |
| Date Mfgr Received | 2008-05-08 |
| 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 | JOSEPH JACOBS, M.D. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617469 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M2000SP INSTRUMENT |
| Generic Name | AUTOMATED SAMPLE PREPARATION SYSTEM |
| Product Code | KEY |
| Date Received | 2008-06-05 |
| Catalog Number | 09K14-01 |
| 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 | 2008-06-05 |