MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-14 for ICON 20 HCG 395097 manufactured by Beckman Coulter, Inc..
[21961064]
A customer contacted beckman coulter inc. (bci) regarding discrepant negative (-) urine test results from the icon 20 hcg test kit for five different pt samples. Patient 1: a urine sample tested with the icon 20 hcg test kit gave a negative (-) result. A serum quantitative test was 42344 (units unknown) and an ultrasound test also was positive (+). The pt was approx 8 weeks pregnant. Patient 2: a urine sample tested with the icon 20 hcg test kit gave a negative (-) result. An ultrasound test was positive (+) and pt was approx 7 weeks pregnant. Patient 3: a urine sample tested with the icon 20 hcg test kit gave a negative (-) result. A home pregnancy test was positive (+), serum quantitative test was 3751 (units unknown) and an ultrasound test also was positive (+). The pt was approx 6 weeks pregnant. Patient 4: a urine sample tested with the icon 20 hcg test kit gave a negative (-) result. A home pregnancy test and another qualitative pregnancy test were positive (+). Patient 5: a urine sample tested with the icon hcg test kit gave a negative (-) result. A home pregnancy test and an ultrasound test were positive (+). The pt was 10 weeks pregnant. No affect to pt has been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[21989021]
Retain devices performed as expected when tested by beckman coulter inc. (bci) with: positive and negative serum and urine controls. Positive clinical urine sample. Bci was not able to conduct an investigation as pt samples and product were not returned by the customer. Based on available info, customer was using liquid urine controls which are not validated for use with the icon 20 hcg test kit. 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 | 2916283-2008-00003 |
| MDR Report Key | 1028760 |
| Report Source | 05 |
| Date Received | 2008-04-14 |
| Date of Report | 2008-04-14 |
| Date of Event | 2008-01-11 |
| Date Mfgr Received | 2008-03-06 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2009-04-29 |
| 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 | NORA ZEROUNIAN, GROUP MGR |
| Manufacturer Street | 200 S. KRAEMER BLVD. P.O BOX 8000, MAIL STOP: W-110 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON 20 HCG |
| Generic Name | QUALITATIVE HCG TEST |
| Product Code | JHJ |
| Date Received | 2008-04-14 |
| Model Number | NA |
| Catalog Number | 395097 |
| Lot Number | 167H11 |
| ID Number | NA |
| Device Expiration Date | 2009-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 10 PAGE MILL RD. PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-14 |