MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-01-05 for MTS ID TIPMASTER PIPETTOR MTS9640 manufactured by Micro Typing Systems, Inc..
[552997]
The customer reported that they had observed an incorrect amount of fluid dispensed from the mts id tipmaster pipettor. Incorrect dispense of fluid may lead to variations in antigen/antibody ratio and possible erroneous test results. The customer indicated that the incorrect dispense of fluid was noticed immediately and testing was not completed, preventing erroneous results from being reported. If this incident were to recur undetected, erroneous results could be reported.
Patient Sequence No: 1, Text Type: D, B5
[7941606]
The pipette is no longer covered under warranty. The customer was instructed to discontinue use of this instrument. The instrument was not returned to mts as such no evaluation could be done. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2007-00006 |
| MDR Report Key | 805569 |
| Report Source | 05,06 |
| Date Received | 2007-01-05 |
| Date of Report | 2007-01-04 |
| Date of Event | 2006-12-08 |
| Date Mfgr Received | 2006-12-08 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2007-01-18 |
| 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 |
| 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 | 2007-01-05 |
| Model Number | NA |
| Catalog Number | MTS9640 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 793083 |
| 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 | 2007-01-05 |