MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2000-12-15 for IMMULITE THYROGLOBULIN KIT LKTY1 manufactured by Diagnostic Products Corporation.
[215090]
Distributor reported that a customer reported obtaining spuriously high results with this kit. Subsequently, the pt was treated, although later investigation determined that this treatment was not necessary. Treatment was not a serious injury, however, it could possibly have been under different circumstances.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2017183-2000-00001 |
MDR Report Key | 309279 |
Report Source | 01,08 |
Date Received | 2000-12-15 |
Date of Report | 2000-12-14 |
Date of Event | 2000-11-14 |
Date Mfgr Received | 2000-11-14 |
Device Manufacturer Date | 2000-03-01 |
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 STREET |
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 THYROGLOBULIN KIT |
Generic Name | IN-VITRO DIAGNOSTIC TEST KIT |
Product Code | MSW |
Date Received | 2000-12-15 |
Model Number | NA |
Catalog Number | LKTY1 |
Lot Number | 216 |
ID Number | NA |
Device Expiration Date | 2001-03-31 |
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 | 299239 |
Manufacturer | DIAGNOSTIC PRODUCTS CORPORATION |
Manufacturer Address | 5700 WEST 96TH STREET LOS ANGELES CA 90045 US |
Baseline Brand Name | IMMULITE THYROGLOBULIN KIT |
Baseline Generic Name | IN-VITR DIAGNOSTIC TEST KIT |
Baseline Model No | NA |
Baseline Catalog No | LKTY1 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2000-12-15 |