MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-22 for HCG COMBO RAPID TEST * B1077-23 manufactured by Alere North America.
[3037054]
Patient presented in the ed with abdominal pain. A urine specimen was obtained and sent to the lab for a qualitative pregnancy test. The test kit showed a negative result. The patient was then sent for a ct scan of the abdomen where the technician noticed a fetus of approximately 17 weeks gestation. A quantitative serum hcg (preganancy) test was ordered with a result of over 67,000 iu/l. The urine pregnancy test was repeated giving the same negative result. On further research, it was discovered that some methodologies give false negative results when the serum hcg concentration is high due to excessive hcg beta core fragments (study by the university of washington reported in "clinical chemistry" 55:10, 2009). In this study, when patients' urine is diluted 1:10, the qualitative result is clearly positive. The department supervisor then performed the qualitiative test with the patient's diluted urine as per the study and produced a clearly positive result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2778608 |
| MDR Report Key | 2778608 |
| Date Received | 2012-08-22 |
| Date of Report | 2012-08-22 |
| Date of Event | 2012-08-15 |
| Report Date | 2012-08-22 |
| Date Reported to FDA | 2012-08-22 |
| Date Added to Maude | 2012-10-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCG COMBO RAPID TEST |
| Generic Name | KIT, TEST, PREGNANCY |
| Product Code | LCX |
| Date Received | 2012-08-22 |
| Model Number | * |
| Catalog Number | B1077-23 |
| Lot Number | HCG2050019 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE NORTH AMERICA |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD 30 S. KELLER ROAD, SUITE 100 ORLANDO FL 32810 US 32810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2012-08-22 |