MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-10-11 for MTS ID TIPMASTER PIPETTOR MTS9640 manufactured by Micro Typing Systems, Inc..
[15163254]
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 observed the issue and took the pipettor out of use, preventing erroneous results from being reported.
Patient Sequence No: 1, Text Type: D, B5
[15391267]
Evaluation of pipettor had not been performed at the time of this report and was pending the return of the equipment. The customer's complaint was resolved by providing equipment replacement. This customer had not logged any complaints against this pipettor since this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2007-00289 |
| MDR Report Key | 925763 |
| Report Source | 05,06 |
| Date Received | 2007-10-11 |
| Date of Report | 2007-10-11 |
| Date of Event | 2007-09-12 |
| Date Mfgr Received | 2007-09-12 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2007-12-04 |
| 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 | AWILDA GERBER, PRINCIPAL SCIENTI |
| Manufacturer Street | 1295 SW 29TH AVENUE |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239567 |
| 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 | 2007-10-11 |
| Model Number | NA |
| Catalog Number | MTS9640 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 911612 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 SW 29TH AVENUE POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-11 |