MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-08-02 for IMX ANALYZER 8389-59 manufactured by Abbott Manufacturing Inc..
[260013]
A pt's serum sample generated an imx bhcg assay result of 1374 mlu/ml. Two days prior, this pt tested with a results of 2808 mlu/ml. The pt was told that their bhcg levels were dropping and they could possibly miscarry. Five days later, another sample was drawn with a result of 26028 mlu/ml. The sample that generated the result of 1374mlu/ml was repeated at this time with a result of 4978 mlu/ml. Controls were within specifications on all runs. The pt's status was moved to pre-natal. There is no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2002-00039 |
| MDR Report Key | 409401 |
| Report Source | 06 |
| Date Received | 2002-08-02 |
| Date of Report | 2002-08-01 |
| Date of Event | 2002-06-28 |
| Date Mfgr Received | 2002-07-05 |
| Device Manufacturer Date | 1993-05-01 |
| Date Added to Maude | 2002-08-09 |
| 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 | 2002-08-02 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 398413 |
| 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 | 2002-08-02 |