MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-01-22 for IMX ANALYZER 8389-59 manufactured by Abbott Manufacturing, Inc..
[39545]
On 11/18/96 an outpt had an hcg test performed on the analyzer for a result of less than 5. 0 miu/ml. The test was reported as negative. The pt visited the dr on 11/28/96 and had a urine hcg test performed for a positive result. A sonogram was performed on 11/28/96 and a reported "fetus was present". The test (specimen from 11/18) was repeated on 11/28 at the lab and reported very high positive results. No quantitative result given by account. The account was not aware of any other treatment rendered to the pt with the discrepant hcg other than the sonogram.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-1997-00008 |
| MDR Report Key | 65333 |
| Report Source | 05 |
| Date Received | 1997-01-22 |
| Date of Report | 1997-01-21 |
| Date of Event | 1996-11-18 |
| Date Mfgr Received | 1996-12-24 |
| Device Manufacturer Date | 1988-08-01 |
| Date Added to Maude | 1997-01-30 |
| 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 | 3 |
| 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 | 1997-01-22 |
| Model Number | NA |
| Catalog Number | 8389-59 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 65427 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-22 |