|
|
| Catalog Number 43025 |
| Event Date 12/05/2003 |
|
Event Type
Other
Patient Outcome
Other;
|
|
Event Description
|
A customer called beckman coulter regarding discrepant urine test result from a pt.
- a urine sample from the pt tested negative (-) with icon 25 hcg test kit.
- the urine sample was retested with another urine rapid test kit and the result was positive.
- no serum sample was collected for quantitative analysis.
There has been no change to pt treatment that can be attributed to this event.
|
| |
|
Manufacturer Narrative
|
No customer devices were returned to beckman coulter.
The pt's urine sample was sent to beckman coulter for further analysis.
A faint positive result was obtained on retains when tested at beckman coulter.
Retained devices exhibited the correct results with controls when tested at beckman coulter.
A malfunction will be assumed for the purpose of this report.
The root cause of event is unk and unknowable.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | ICON 25 HCG |
|---|
| Type of Device | QUALITATIVE HCG TEST |
|---|
| Baseline Brand Name | ICON 25 HCG |
|---|
| Baseline Generic Name | QUALITATIVE BHCG TEST |
|---|
| Baseline Catalogue Number | 43025 |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Manufacturer (Section F) |
| BECKMAN COULTER INC. |
| 1050 page mill rd |
| palo alto CA 94304 0803 |
|
| Manufacturer (Section D) |
| BECKMAN COULTER INC. |
| 1050 page mill rd |
| palo alto CA 94304 0803 |
|
| Manufacturer Contact |
|
anne
saber director
|
| 11800 sw 147th ave |
| mail stop: 32-c06 |
| miami
, FL 33116-9015 |
| (305)
380
-2618
|
|
| Device Event Key | 496245 |
|---|
| MDR Report Key | 507311 |
|---|
| Event Key | 481190 |
|---|
| Report Number | 2916283-2003-00040 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | JHI |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
Health Professional
|
|---|
| Reporter Occupation |
NO INFORMATION
|
| Remedial Action |
Other
|
| Type of Report
| Initial |
|---|
| Report Date |
12/19/2003 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 12/22/2003 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device Catalogue Number | 43025 |
|---|
| Device LOT Number | HCG030732 |
|---|
| Was Device Available For Evaluation? |
No Answer Provided
|
|---|
| Is The Reporter A Health Professional? |
Unknown
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Was Device Evaluated By Manufacturer? |
No
|
|---|
| Date Device Manufactured | 07/01/2003 |
|---|
| Is The Device Single Use? |
Yes
|
|---|
| Is this a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
|
|---|
| Type of Device Usage |
Invalid Data
|
|---|
|
|
Database last updated on January 30, 2009
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