MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-07-11 for PEGASYS 2144-3000A * manufactured by Adac Laboratories.
[15675937]
When activated, autoquant is not normalizing according to the given parameters. It includes areas not inside the regions and performs some type of averaging. This may cause images to be mis-represented. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916556-2000-00296 |
| MDR Report Key | 286126 |
| Report Source | 05 |
| Date Received | 2000-07-11 |
| Date of Report | 2000-06-28 |
| Date of Event | 2000-03-29 |
| Date Facility Aware | 2000-03-29 |
| Report Date | 2000-03-29 |
| Date Mfgr Received | 2000-03-29 |
| Date Added to Maude | 2000-07-20 |
| 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 | 3 |
| Manufacturer Contact | CLIFF CASE, DIR. |
| Manufacturer Street | 540 ALDER DR |
| Manufacturer City | MILPITAS CA 950357443 |
| Manufacturer Country | US |
| Manufacturer Postal | 950357443 |
| Manufacturer Phone | 4084683151 |
| Manufacturer G1 | ADAC LABORATORIES |
| Manufacturer Street | 540 ALDER DRIVE |
| Manufacturer City | MILPITAS CA 95035744 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 7443 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEGASYS |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IXY |
| Date Received | 2000-07-11 |
| Model Number | 2144-3000A |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | V3.4 SW Y2K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 276875 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DR MILPITAS CA 950357443 US |
| Baseline Brand Name | GENESYS |
| Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Baseline Model No | 2144-3000A |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NUCLEAR MEDICINE EQUIPMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900689 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-07-11 |