MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-02-13 for ICON 25 HCG 43025 manufactured by Beckman Coulter Inc..
[364316]
The customer indicated that an emergency room (er) pt had a urine sample tested with an icon 25 hcg test kit and the hcg result was negative (-). The er physician did not believe the negative urine test result and requested a serum sample to be tested quantitatively for hcg. The customer indicated that the physician did not provide a specific reason as to why the icon 25 hcg result was not accepted. The pt's serum sample was sent to the lab for a serum quantitative bhcg. The quantitative bhcg result was 150 miu/ml. There has been no change to pt treatment that can be attributed to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916283-2004-00001 |
| MDR Report Key | 524450 |
| Report Source | 05 |
| Date Received | 2004-02-13 |
| Date of Report | 2004-02-13 |
| Date of Event | 2004-01-15 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2004-05-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANNE SABER DIRECTOR |
| Manufacturer Street | 11800 SW 147TH AVE MAIL STOP: 32-C06 |
| Manufacturer City | MIAMI FL 331169015 |
| Manufacturer Country | US |
| Manufacturer Postal | 331169015 |
| Manufacturer Phone | 3053802618 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NOT APPLICABLE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON 25 HCG |
| Generic Name | QUALITATIVE HCG TEST |
| Product Code | JHJ |
| Date Received | 2004-02-13 |
| Model Number | NA |
| Catalog Number | 43025 |
| Lot Number | HCG030802 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 497745 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 1050 PAGE MILL ROAD PALO ALTO CA 94304 US |
| Baseline Brand Name | ICON 25 HCG |
| Baseline Generic Name | QUALITATIVE BHCG TEST |
| Baseline Model No | NA |
| Baseline Catalog No | 43025 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-13 |