MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-02-07 for ICON II HCGSU 4135 manufactured by Beckman Coulter, Inc..
[452840]
A customer contacted beckman coulter regarding falsely negative (-) serum test results from the icon ii hcgsu test kit. The customer indicated that a single pt had serum sample tested with the icon ii hcgsu test kit in 2005. The result was negative (-). The customer indicated that the pt was prescribed a hormone, provera. Early 2006, the pt returned to her family physician who noticed that the pt looked pregnant. A fetal heart beat was detected through an ultrasound test. The customer indicated that the physician was was able to determine that the pt was 10-12 weeks pregnant at the time when tested with the icon ii hcgsu test kit. The customer indicated that the projected delivery date is 03/2006. No additional info regarding this event was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916283-2006-00004 |
| MDR Report Key | 673994 |
| Report Source | 05 |
| Date Received | 2006-02-07 |
| Date of Report | 2006-02-07 |
| Date of Event | 2005-09-07 |
| Date Mfgr Received | 2006-01-25 |
| Date Added to Maude | 2006-02-15 |
| 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 | NORA ZEROUNIAN, SPECIALIST |
| Manufacturer Street | 200 S. KRAEMER BLVD PO BOX 8000, MAIL STOP: W-110 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON II HCGSU |
| Generic Name | QUALITATIVE HCGSU TEST |
| Product Code | JHJ |
| Date Received | 2006-02-07 |
| Model Number | NA |
| Catalog Number | 4135 |
| Lot Number | NOT PROVIDED |
| 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 | 663282 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 10 PAGE MILL ROAD PALO ALTO CA 94304 US |
| Baseline Brand Name | ICON II HCGSU |
| Baseline Generic Name | QUALITATIVE HCGSU TEST |
| Baseline Model No | NA |
| Baseline Catalog No | 4135 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-07 |