MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-28 for ICON 25 HCG 43025 manufactured by Beckman Coulter, Inc..
[800083]
A customer contacted beckman coulter regarding falsely negative (-) urine test results from the icon 25 hcg test kit. Pt a: a urine sample was tested with the icon 25 hcg test kit and a negative (-) result was obtained. A serum quantitative test gave a result of 4600miu/ml. A 2nd urine sample was tested with the icon 25 hcg on the next day and result also was negative (-). A serum quantitative test was performed again and a result of 4189miu/ml was obtained. The customer then ran quantitative test on both urine samples and results were: 527miu/ml and 215miu/ml respectively. Pt b: a urine sample was tested with the icon 25 hcg test kit and a negative (-) result was obtained. A serum quantitative test gave a result of 31. 628miu/ml. Customer reported later that they were able to confirm positive (+) results, and there was no discrepancy for this pt. No injury related to this event has been reported.
Patient Sequence No: 1, Text Type: D, B5
[8032089]
Retain devices performed as expected when tested by beckman coulter inc. (bci) with: positive and negative serum and urine controls. Low, medium and high positive quantitative clinical urine sample. Customer return urine and serum samples from pt a. All results obtained by bci were positive (+). Based on avail info, the 2nd sample from pt a was very dark, migrated very slowly and gave lots of purple background when tested with the icon 25 test kit. Complaint was neither verified nor confirmed as positive results were obtained with the icon 25 hcg devices, matching quantitative hcg results. 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 | 2916283-2008-00001 |
| MDR Report Key | 1005879 |
| Report Source | 05 |
| Date Received | 2008-02-28 |
| Date of Report | 2008-02-28 |
| Date of Event | 2008-02-11 |
| Date Mfgr Received | 2008-02-14 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-05-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANNE SABER, PH.D, DIR |
| Manufacturer Street | 11800 SW 147TH AVE MAIL STOP: 31-B06 |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal | 33196 |
| Manufacturer Phone | 3053802618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON 25 HCG |
| Generic Name | QUALITATIVE HCG TEST |
| Product Code | JHJ |
| Date Received | 2008-02-28 |
| Model Number | NA |
| Catalog Number | 43025 |
| Lot Number | HCG7089003 |
| ID Number | NA |
| Device Expiration Date | 2009-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1003753 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 10 PAGE MILL RD PALO ALTO CA 94304 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-28 |