MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-04-27 for MTS READER M MTS9940 ORTHO PROVUE manufactured by Micro Typing Systems, Inc..
[448330]
The customer reported that the reader m misread a barcode on an mts anti-ig card.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056600-2006-00060 |
| MDR Report Key | 707432 |
| Report Source | 06 |
| Date Received | 2006-04-27 |
| Date of Report | 2006-04-25 |
| Date of Event | 2006-03-27 |
| Date Mfgr Received | 2006-03-27 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2006-05-04 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID HAGEN MANAGER Q/R/C |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS READER M |
| Generic Name | RESULT READER FOR MTS GEL CARDS |
| Product Code | KSO |
| Date Received | 2006-04-27 |
| Model Number | MTS9940 |
| Catalog Number | ORTHO PROVUE |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 696496 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS READER M |
| Baseline Generic Name | RESULT READER FOR MTS GEL CARDS |
| Baseline Model No | MTS9940 |
| Baseline Catalog No | ORTHO PROVUE |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-27 |