MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-12-23 for ABBOTT AXSYM SYSTEM 7A83-01 manufactured by Abbott Manufacturing, Inc..
[350117]
A physician questioned an axsym bhcg result of 701 miu/ml on a pt suspected of having either a hydatid mole or ectopic pregnancy. The pt previously tested at 3,541 miu/ml. The pt was redrawn yielding a result of 2,082 miu/ml. The sample in question was retested twice yielding results of 2,498 and 3,013 miu/ml. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2003-00017 |
| MDR Report Key | 507594 |
| Report Source | 05,06 |
| Date Received | 2003-12-23 |
| Date of Report | 2003-12-17 |
| Date of Event | 2003-11-09 |
| Date Mfgr Received | 2003-11-21 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2004-01-26 |
| 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 SPINDELL, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT AXSYM SYSTEM |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JHE |
| Date Received | 2003-12-23 |
| Model Number | NA |
| Catalog Number | 7A83-01 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 496541 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Baseline Brand Name | ABBOTT AXSYM SYSTEM |
| Baseline Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 7A83-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-23 |