MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-12-07 for ARCHITECT LH 6C25-22 manufactured by Abbott Laboratories.
| Report Number | 1415939-2006-00056 |
| MDR Report Key | 795641 |
| Report Source | 01,06 |
| Date Received | 2006-12-07 |
| Date of Report | 2006-11-28 |
| Date of Event | 2006-08-18 |
| Date Mfgr Received | 2006-11-28 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-12-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-11/29/06-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT LH |
| Generic Name | CMIA FOR THE QUANTITATIVE DEMONSTRATION OF HUMAN LUTEINIZING |
| Product Code | CEP |
| Date Received | 2006-12-07 |
| Model Number | NA |
| Catalog Number | 6C25-22 |
| Lot Number | 33198M200 |
| ID Number | NA |
| Device Expiration Date | 2007-06-16 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 783219 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | ARCHITECT LH |
| Baseline Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF HUMAN LUTEINIZING |
| Baseline Model No | NA |
| Baseline Catalog No | 6C25-22 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-07 |