MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-04-19 for MTS DISPENSER 0.5ML MTS9610 manufactured by Micro Typing Systems, Inc..
[737094]
The customer reported that mts dispenser did not dispense the correct amount of fluid during testing. Incorrect dispense of fluid, may lead to variations in antigen / antibody ratio and possible erroneous test results. The customer aborted testing once the issue was identified. The dispenser was taken out of use, preventing erroneous results from being reported.
Patient Sequence No: 1, Text Type: D, B5
[8009631]
The dispenser was not returned for investigation. No definitive root cause could be determined. Issue resolved via product replacement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2007-00099 |
| MDR Report Key | 939972 |
| Report Source | 05,06 |
| Date Received | 2007-04-19 |
| Date of Report | 2007-04-19 |
| Date of Event | 2007-03-20 |
| Date Mfgr Received | 2007-03-20 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2007-11-09 |
| 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 S.W. 29TH AVE. |
| 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 DISPENSER 0.5ML |
| Generic Name | MANUAL DISPENSER |
| Product Code | GJG |
| Date Received | 2007-04-19 |
| Model Number | NA |
| Catalog Number | MTS9610 |
| Lot Number | 40295 |
| 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 | 912031 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-19 |