MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-16 for MTS 24 PLACE CENTRIFUGE MTS515060 manufactured by Micro Typing Systems, Inc..
[16909672]
The customer reported the mts centrifuge was not operating at the correct speed. Gel cards centrifuged at improper speed could results in erroneous results. No erroneous test results were reported there was no report of harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[16951451]
Investigation into this event found that the user observed the issue and aborted testing, thereby preventing erroneous results from being reported. The centrifuge was returned to the service depot confirmed the customer's complaint. The root cause of the event is unk. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00211 |
| MDR Report Key | 2971445 |
| Report Source | 05,06 |
| Date Received | 2006-10-16 |
| Date of Report | 2006-10-13 |
| Date of Event | 2005-04-13 |
| Date Mfgr Received | 2005-04-13 |
| Device Manufacturer Date | 2001-10-01 |
| Date Added to Maude | 2013-02-22 |
| 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 | DAVID HAGEN, SITE MGR |
| Manufacturer Street | 1295 S.W. 29TH AVE. |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239526 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS 24 PLACE CENTRIFUGE |
| Generic Name | CENTRIFUGE |
| Product Code | KSO |
| Date Received | 2006-10-16 |
| Model Number | NA |
| Catalog Number | MTS515060 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-16 |