MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-10 for MTS ID TIPMASTER PIPETTOR MTS9640 6900954 manufactured by Micro Typing Systems, Inc..
[17864783]
A customer reported that the pipettor was leaking. This could result in variable delivery of reagents. Dispensing variable volumes of reagents/samples could cause erroneous test results. There was no report of patient harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[18016588]
The customer removed the pipettor from service and performed maintenance using the tipmaster maintenance kit. Cleaning, re-greasing and hanging the o-rings brought the device back to expected operation. Though the most likely root cause of the event is user error in maintaining the pipettor, the possibility of pipette malfunction could not be ruled out.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00280 |
| MDR Report Key | 781534 |
| Report Source | 05,06 |
| Date Received | 2006-11-10 |
| Date of Report | 2006-11-10 |
| Date of Event | 2006-05-20 |
| Date Mfgr Received | 2006-05-20 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2006-11-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2006-11-10 |
| Model Number | MTS9640 |
| Catalog Number | 6900954 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 769319 |
| 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 | 2006-11-10 |