MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-12 for HCG ONE STEP PREGNANCY TEST STRIP (URINE) FHC-101 manufactured by Alere San Diego.
[188842016]
Results pending completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[188842017]
The customer reported that a patient with two at home positive pregnancy tests had a false negative result on an hcg test. An hcg test with a blood sample confirmed pregnancy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00004 |
| MDR Report Key | 9703045 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-12 |
| 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 | 3 |
| Manufacturer Contact | MONIKA BURRELL |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 8052506 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCG ONE STEP PREGNANCY TEST STRIP (URINE) |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-02-12 |
| Model Number | FHC-101 |
| Lot Number | HCG8090102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO |
| Manufacturer Address | 9995 SUMMERS RIDGE RD SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |