MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-08-28 for THEOPHYLLINE MONOCLONAL II REAGENT 8A53-85 manufactured by Abbott Diagnostics Int'l, Ltd.
| Report Number | 2623532-2008-00016 |
| MDR Report Key | 1145510 |
| Report Source | 01 |
| Date Received | 2008-08-28 |
| Date of Report | 2008-08-21 |
| Date Mfgr Received | 2008-08-21 |
| Date Added to Maude | 2009-05-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KHAUDEJA BANO, M.D. |
| Manufacturer Street | 100 ABBOTT PARK ROAD D09Y6, AP6C-2 |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479386319 |
| Manufacturer G1 | ABBOTT DIAGNOSTICS INT'L, LTD |
| Manufacturer Street | KM 58.0 CARRETERA 2 CRUCE DAVILA |
| Manufacturer City | BARCELONETA PR 00617 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00617 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THEOPHYLLINE MONOCLONAL II REAGENT |
| Generic Name | FPIA FOR THE QUANTITATIVE MEASUREMENT OF THEOPHYLLINE IN SERUM OR PLASMA |
| Product Code | LGS |
| Date Received | 2008-08-28 |
| Model Number | NA |
| Catalog Number | 8A53-85 |
| Lot Number | 56445Q100 |
| ID Number | NA |
| Device Expiration Date | 2009-04-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS INT'L, LTD |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US 00617 |