MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-06-15 for IMX ANALYZER 8389-59 manufactured by Abbott Mfg, Inc..
[120002]
On 5/19/1998 the account reported a discrepant imx total beta human chorionic gonadotropin result and the pt was scheduled for a dilatation and curettage because of the result. The specimen was run in dilution mode on 5/19/1998 and a result of 433 miu/ml was given. The sample was retested on 5/20/1998 in the dilution mode, giving 466 miu/ml. The pt had a previous result of 650 miu/ml on 5/15/1998. The specimen was sent to another lab and run on the axsym analyzer and a result of 1727 miu/ml was given. The dilatation and curettage was then cancelled. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[22118340] A field svc rep (fsr) visited the account to evaluate the sys. The optics were replaced by the fsr, and the meia photo calibration, carousel calibration and dispense check were performed. Precision runs were also performed on diluted specimens and all cvs were Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-1998-00056 |
| MDR Report Key | 173061 |
| Report Source | 05,06 |
| Date Received | 1998-06-15 |
| Date of Report | 1998-06-11 |
| Date of Event | 1998-05-19 |
| Date Mfgr Received | 1998-05-20 |
| Device Manufacturer Date | 1995-09-01 |
| Date Added to Maude | 1998-06-22 |
| 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 |
| 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 | 1998-06-15 |
| Model Number | NA |
| Catalog Number | 8389-59 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 168273 |
| Manufacturer | ABBOTT MFG, 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 | 1998-06-15 |