MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-01 for MTS ID TIPMASTER PIPETTOR MTS9640 manufactured by Micro Typing Systems, Inc..
[600159]
The customer reported that the mts-id tipmaster pipettor was not dispensing the correct amount of volume.
Patient Sequence No: 1, Text Type: D, B5
[7927434]
The customer reported that the mts id tipmaster pipettor did not dispense the proper amount of fluid. It is unk which tests were being performed at the time of the incident. No definitive root cause was determined concerning the incorrect dispense of the pipettor. The customer detected the reported issue (following labeling recommendations), and then removed the pipettor from use preventing the reporting of erroneous test results. The customer was advised to contact their ocd account mgr regarding purchase of a replacement pipettor, since the instrument was out of warranty. Labeling cautions on the importance of delivering the correct amount of cells and plasma/serum when performing the gel test method. The instrument is a handheld pipettor. The pipettor is used in preparing a manual gel test. A laboratory technician closely monitors all tests. All tests are qualitative. Although laboratory practices mitigate the possibility of erroneous pt results, if the alleged malfunction were to recur undetected, it could lead to erroneous test results. Therefore, incident is reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00324 |
| MDR Report Key | 827109 |
| Report Source | 06 |
| Date Received | 2006-11-01 |
| Date of Report | 2006-10-31 |
| Date of Event | 2006-09-29 |
| Date Mfgr Received | 2006-09-29 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2007-03-14 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID HAGEN, SITE MANAGER |
| Manufacturer Street | 1295 SW 29TH AVENUE |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239528 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS ID TIPMASTER PIPETTOR |
| Generic Name | MANUAL PIPETTOR |
| Product Code | GJG |
| Date Received | 2006-11-01 |
| Model Number | MTS9640 |
| Catalog Number | TIPMASTER PIPETTOR |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 814506 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS ID TIPMASTER PIPETTOR |
| Baseline Generic Name | MANUAL PIPETTOR |
| Baseline Model No | MTS9640 |
| Baseline Catalog No | ID TIPMASTER PIPETTOR |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-01 |