MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-09-11 for IMX ANALYZER 8389-59 manufactured by Abbott Manufacturing, Inc..
[103676]
On 08/12/1998 the account reported a bhcg result of 2688 miu/ml for a sample tested with "imx" bhcg" reagent list number 1a06-20. The account retested the sample with "imx bhcg" reagent list number 1a06-22 and obtained results of 6090/5728 miu/ml. The sample was retested with imx bhcg" reagent list number 1a06-20 and a result of 2748 miu/ml was obtained. All testing was performed with the automated 1:200 dilution. The customer then sent the sample to a reference lab for testing and a result of 19,089 miu/ml was obtained. According to the account, after svc changed the worn pump belt on the instrument, the bhcg results correlated between both "imx" reagent list numbers and the reference lab methodology. The exact concentrations obtained were not provided by the account. No sample was available from the reference lab to verify test results after maintenance performed. No report of injury due to the initial reported result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-1998-00079 |
| MDR Report Key | 187359 |
| Report Source | 05,06 |
| Date Received | 1998-09-11 |
| Date of Report | 1998-09-10 |
| Date of Event | 1998-08-12 |
| Date Mfgr Received | 1998-08-12 |
| Device Manufacturer Date | 1995-10-01 |
| Date Added to Maude | 1998-09-16 |
| 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 | 1998-09-11 |
| Model Number | NA |
| Catalog Number | 8389-59 |
| 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 | 182112 |
| 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 | 1998-09-11 |