MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-10-09 for IMX ANALYZER 8389-59 manufactured by Abbott Manufacturing, Inc..
[266973]
A physician questioned an initial imx bhcg assasy result of 914 mlu/ml. The patient (possible ectopic pregnancy) was redrawn and tested two days later and generated a result of 5580. 10 mlu/ml. An ultrasound was performed and confirmed a viable pregnancy. The initial sample was retested and generated a result of 3124 mlu/ml. All controls were within specifications on all runs. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2002-00055 |
| MDR Report Key | 422335 |
| Report Source | 06 |
| Date Received | 2002-10-09 |
| Date of Report | 2002-10-09 |
| Date of Event | 2002-09-23 |
| Date Mfgr Received | 2002-09-25 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2002-10-18 |
| 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 Contact | PAUL LANDESMAN |
| Manufacturer Street | 100 ABBOTT PARK ROAD D-09D5, AP6C-6 |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643500 |
| Manufacturer Phone | 8479372688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | LCI |
| Date Received | 2002-10-09 |
| Model Number | NA |
| Catalog Number | 8389-59 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 411391 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR IRVING TX 75038 US |
| Baseline Brand Name | IMX ANALYZER(REFURB) |
| Baseline Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 8389-59 |
| Baseline ID | NA |
| Baseline Device Family | IMX |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K864319 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-10-09 |