MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2000-12-15 for IMMULITE TURBO TROPONIN KIT N/A LSKTI manufactured by Diagnostic Products Corporation.
[202784]
Customer reported receiving falsely elevated test results with this kit. Subsequently, the pt was treated, although later investigation determined that treatment was not necessary. Treatment was not a serious injury; however it could have possibly been under different circumstances.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017183-2000-00002 |
| MDR Report Key | 309281 |
| Report Source | 08 |
| Date Received | 2000-12-15 |
| Date of Event | 2000-11-17 |
| Date Mfgr Received | 2000-11-17 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2000-12-22 |
| 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 Street | 5700 WEST 96TH ST |
| Manufacturer City | LOS ANGELES CA 90045 |
| Manufacturer Country | US |
| Manufacturer Postal | 90045 |
| Manufacturer Phone | 3106458200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE TURBO TROPONIN KIT |
| Generic Name | IN-VITRO DIAGNOSTIC TEST KIT |
| Product Code | LYR |
| Date Received | 2000-12-15 |
| Model Number | N/A |
| Catalog Number | LSKTI |
| Lot Number | 114 |
| ID Number | NA |
| Device Expiration Date | 2001-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 299241 |
| Manufacturer | DIAGNOSTIC PRODUCTS CORPORATION |
| Manufacturer Address | 5700 WEST 96TH STREET LOS ANGELES CA 90045 US |
| Baseline Brand Name | IMMULITE TURBO |
| Baseline Generic Name | IVD TEST KIT |
| Baseline Catalog No | LSKTI |
| Baseline Device Family | IMMULITE IMMUNOASSAY KIT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K000463 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-12-15 |