MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-01 for MTS 24 PLACE CENTRIFUGE MT515060 manufactured by Micro Typing Systems, Inc..
[819855]
The customer reported that the mts 24 place centrifuge was not in specification. The user detected the issue and retested using an alternate centrifuge preventing erroneous results from being reported. Incorrect centrifugation speed or time during testing, if undetected, may lead to erroneous test results.
Patient Sequence No: 1, Text Type: D, B5
[8030627]
No definitive root cause was determined. The centrifuge was out of warranty. The customer's bio med tech was instructed to check the gel cardholders for free movement. This customer has not logged any complaints against this instrument since this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2008-00105 |
| MDR Report Key | 1022660 |
| Report Source | 05,06 |
| Date Received | 2008-04-01 |
| Date of Report | 2008-04-01 |
| Date of Event | 2008-03-10 |
| Date Mfgr Received | 2008-03-10 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2008-10-07 |
| 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 | JENNIFER SPARROW |
| Manufacturer Street | 1001 US ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9087043872 |
| Single Use | 3 |
| 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 | 2008-04-01 |
| Model Number | NA |
| Catalog Number | MT515060 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1020745 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-01 |