MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-17 for MTS DISPENSE 1.0ML MTS9612 MTS DISPENSER manufactured by Micro Typing Systems, Inc..
[17017006]
The customer reported that the 1. 0 ml mts dispenser was leaking and not dispensing the correct amount of volume. It is unknown if the instrument was being used for patient testing at the time of the incident.
Patient Sequence No: 1, Text Type: D, B5
[17233530]
The customer reported that the mts dispenser was leaking and not dispensing properly. It is unknown if the issue was observed during testing. Customer labeling instructs customer to perform qc prior to all testing involving mts gel cards. Variations in red blood cell concentration can markedly affect the sensitivity of test results. If red blood cell suspensions are too concentrated, they can give weaker results due to the increase in the antigen/antibody ratio. In addition, red blood cells may fail to completely migrate to the bottom of the microtube and could cause a false positive interpretation. When red blood cells are too low in concentration, they become difficult to visualize, and in extreme cases, a weak positive can fail to be detected. Erroneous results were not reported as a result of this incident. The customer issue was resolved via replacement of product. Although these mitigations exist if the incident were to recur undetected a possible erroneous result may occur. The issue was not identified during a calibration of qc. Therefore, incident is reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00260 |
| MDR Report Key | 789115 |
| Report Source | 06 |
| Date Received | 2006-11-17 |
| Date of Report | 2006-11-17 |
| Date of Event | 2006-10-19 |
| Date Mfgr Received | 2006-10-19 |
| Date Added to Maude | 2006-12-05 |
| 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 DISPENSE 1.0ML |
| Generic Name | MTS DISPENSER 1.0ML |
| Product Code | GJG |
| Date Received | 2006-11-17 |
| Model Number | MTS9612 |
| Catalog Number | MTS DISPENSER |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 776796 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS DISPENSE 1.0ML |
| Baseline Generic Name | MTS DISPENSER 1.0ML |
| Baseline Model No | MTS9612 |
| Baseline Catalog No | MTS DISPENSER |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-17 |