MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-11-11 for ID-MTS READER SA MTS9945 manufactured by Micro Typing Systems, Inc..
[342496]
The customer reported obtaining weak d negative results with the mts reader sa with a known weak d positive donor. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058138-2003-00011 |
| MDR Report Key | 496603 |
| Report Source | 06 |
| Date Received | 2003-11-11 |
| Date of Report | 2003-11-11 |
| Date of Event | 2003-10-04 |
| Date Mfgr Received | 2003-10-13 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2003-11-21 |
| 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 | CATHERINE MCMULLEN, SITE DIRECTOR |
| Manufacturer Street | 1295 SW 29TH AVE. |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239537 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ID-MTS READER SA |
| Generic Name | BLOOD GROUPING CENTRIFUGE AND READER |
| Product Code | KSO |
| Date Received | 2003-11-11 |
| Model Number | MTS9945 |
| Catalog Number | MTS READER SA |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 485339 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 SW 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS READER SA |
| Baseline Generic Name | BLOOD GROUPING CENTRIFUGE AND READER |
| Baseline Model No | MTS9945 |
| Baseline Catalog No | MTS9945 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K000018 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-11 |