MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-16 for ID TIPMASTER MTS9640 6900954 manufactured by Micro Typing Systems, Inc..
[556144]
A customer observed that the tipmaster pipettor is not aspirating properly. Improper aspiration volume could lead to erroneous test results. There was no report of harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8057723]
The pipette was returned to the manufacturer and the complaint was verified. The customer was sent a replacement pipette. Product labeling instructs the user to perform qc or verification daily, minimizing the possibility of erroneous results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00281 |
| MDR Report Key | 785892 |
| Report Source | 05,06 |
| Date Received | 2006-11-16 |
| Date of Report | 2006-11-16 |
| Date of Event | 2005-01-24 |
| Date Mfgr Received | 2005-01-24 |
| Date Added to Maude | 2006-11-24 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ID TIPMASTER |
| Generic Name | INSTRUMENT |
| Product Code | GJG |
| Date Received | 2006-11-16 |
| Model Number | MTS9640 |
| Catalog Number | 6900954 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 773691 |
| 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 | 2006-11-16 |