MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-12 for ICON II HCGU 4134 manufactured by Beckman Coulter, Inc..
[696171]
A customer contacted beckman coulter regarding falsely negative (-) urine test results from the icon ii hcgu test kits. The customer indicated that 2 in vitro fertilization patients (a and b) have tested positive (+) on home pregnancy tests. (tests name and brand not provided) both patients brought first morning void urine samples to the lab and were tested for human chorionic gonadotropin (hcg) with the icon ii hcgu test kits. Hcg results obtained from the icon ii hcgu test kits were negative (-). The customer indicated that they have no additional data, information or samples for patient a. A serum sample from patient b was tested by quantitative method for hcg and a result of 960mlu/ml was obtained. No affect to patients have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[7863900]
No samples were returned for testing. Beckman coulter investigation with retain devices using positive and negative urine controls indicate product performance with expected results. No additional information regarding this event was provided. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916283-2007-00005 |
| MDR Report Key | 914139 |
| Report Source | 05 |
| Date Received | 2007-03-12 |
| Date of Report | 2007-03-12 |
| Date of Event | 2007-02-15 |
| Date Mfgr Received | 2007-02-16 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2007-09-18 |
| 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, MANAGER |
| Manufacturer Street | 200 S. KRAEMER BOULEVARD 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 HCGU |
| Generic Name | QUALITATIVE HCGU TEST |
| Product Code | JHJ |
| Date Received | 2007-03-12 |
| Model Number | NA |
| Catalog Number | 4134 |
| Lot Number | M610227 |
| ID Number | NA |
| Device Expiration Date | 2007-12-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 887294 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 10 PAGE MILL ROAD PALO ALTO CA 94304 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-12 |