MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-08 for ATOMLAB 950 THYROID UPTAKE SYSTEM ATOMLAB 950 PC 187-140 manufactured by Biodex Medical Systems,.
[202209]
Device produces erroneous thyroid uptake values due to an apparent software error. Device also does not perform to mfrs spec in count rate capability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021046 |
| MDR Report Key | 315722 |
| Date Received | 2001-02-08 |
| Date of Report | 2001-02-08 |
| Date Added to Maude | 2001-02-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATOMLAB 950 THYROID UPTAKE SYSTEM |
| Generic Name | THYROID RADIOACTIVE IODINE UPTAKE SCINTILLATION PROBE |
| Product Code | IZD |
| Date Received | 2001-02-08 |
| Model Number | ATOMLAB 950 PC |
| Catalog Number | 187-140 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 305312 |
| Manufacturer | BIODEX MEDICAL SYSTEMS, |
| Manufacturer Address | BROKKHAVEN R&D PLAZA 20 RAMSAY RD, BOX 702 SHIRLEY NY 119670702 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-02-08 |