MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-02-28 for MTS READER SA manufactured by Micro Typing Systems, Inc..
[19143385]
On the night shift, when the tech went to export results to the interface, the interface did not receive all the results, and some of the results appeared changed. Customer was asked to fax results and lis printouts, rerun samples and export the data to verify operation of instrument. Upon rerun, the customer had multiple gel cards listed for the same sample, and the customer reported that the results received on the cerner side of the interface did not match those in the reader sa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058138-2003-00001 |
| MDR Report Key | 446132 |
| Report Source | 05,06 |
| Date Received | 2003-02-28 |
| Date of Report | 2003-02-28 |
| Date of Event | 2003-01-30 |
| Date Mfgr Received | 2003-01-30 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2003-03-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CATHERINE MCMULLEN, MGR. |
| Manufacturer Street | 1295 SW29 AVENUE |
| 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 | MTS READER SA |
| Generic Name | BLOOD GROUPING CENTRIFUGE & READER |
| Product Code | KSO |
| Date Received | 2003-02-28 |
| Model Number | MTS READER SA |
| Catalog Number | MTS READER SA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 435098 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1000 N.W. 56TH ST. FORT LAUDERDALE FL 33309 US |
| Baseline Brand Name | MTS READER SA |
| Baseline Generic Name | BLOOD GROUPING CENTRIFUGE & READER |
| Baseline Model No | MTS READER SA |
| Baseline Catalog No | MTS READER SA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-02-28 |