MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-11 for ICON II HCGSU 4135 manufactured by Beckman Coulter, Inc..
[754013]
A customer contacted beckman coulter regarding falsely negative (-) serum test result from the icon ii hcgsu test kit. In 2007, a pt serum sample was tested with the icon ii hcgsu test kit and a negative (-) result was obtained. Serum quantitative test was performed on that day and a result of 57mlu/ml was obtained. The customer indicated that a week later a serum sample from this pt was tested for hcg by quantitative method and the result was of 92mlu/ml. The pt returned for hcg testing 3rd time 10 days later, and the results were: serum quantitative result was in the range of 93-97 mlu/ml. Urine qualitative test was positive (+). The icon ii hcgsu result was negative (-). No affect to pt has been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8095376]
Beckman coulter tested retain devices using positive and negative serum controls and the product performed within expected results. Pt samples were not returned for testing. The customer performed a dilution study and an interference study on pt's samples and the studies indicate the positive result (+) on urine sample, serum quantitative are the "real" results and the negative (-) results from the icon ii hcgsu test kit are the discrepant results. A possibility hcg or hcg-like substance is under investigation by the customer. A clear root cause has not been determined for this event. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916283-2007-00009 |
| MDR Report Key | 973161 |
| Report Source | 05 |
| Date Received | 2007-04-11 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-09 |
| Date Mfgr Received | 2007-03-20 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2008-01-04 |
| 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 |
| Remedial Action | OT |
| 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 | 2007-04-11 |
| Model Number | NA |
| Catalog Number | 4135 |
| Lot Number | M610352 |
| ID Number | NA |
| Device Expiration Date | 2007-06-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 941586 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 10 PAGE MILL RD. PALO ALTO CA 94304 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-11 |