MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-08 for M2000SP INSTRUMENT 9K14-01 manufactured by Abbott Molecular, Inc..
[662546]
After a recent internal company complaint, it has been identified that spring clips on disposable tip (diti) racks may have sharp protruding edges. In the associated complaint, after removing the diti rack from a developmental version of the m2000sp during evaluation, testing and removing the tips from the rack, a glove was torn and an abbott molecular employee's finger was scratched. This observation of sharp spring clip edges has no effect on m2000sp operation or functionality, and no impact on patient results. The sharp edge of the diti rack's spring clip may cause personal injury of a scratch or cut. This injury carries risk of infection. The exposed spring clips do not normally contact biohazardous material, but are inside the instrument in close proximity to potentially biohazardous substances. Weekly decontamination procedures are recommended within the operations manual maintenance procedures and operators are to be trained in compliance with good laboratory practices and general biohazard and safety.
Patient Sequence No: 1, Text Type: D, B5
[7962744]
It has recently been identified that spring clips on diti racks may have sharp protruding corners. After removing the diti can from a developmental m2000sp, gloves were torn and the finger scratched of an abbott molecular employee. An additional abbott molecular employee cut a finger while working on a diti can in a machine shop (non-standard user environment) enough to draw blood. Three additional observations of sharp edges were documented, although these observations did not result in injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2007-00001 |
| MDR Report Key | 862701 |
| Report Source | 07 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-05-14 |
| Date of Event | 2007-05-10 |
| Date Mfgr Received | 2007-05-14 |
| Date Added to Maude | 2008-02-11 |
| 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 | TIMOTHY STENZEL, MD, PHD |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617133 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 3005248192-06/06/07-002- |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M2000SP INSTRUMENT |
| Generic Name | AUTOMATED SAMPLE PREPARATION SYSTEM |
| Product Code | KEY |
| Date Received | 2007-06-08 |
| Catalog Number | 9K14-01 |
| Lot Number | MULTIPLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 959841 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | DES PLAINES IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-08 |