MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-12 for HCG ONE STEP PREGNANCY TEST STRIP (URINE) FHC-102 manufactured by Alere San Diego.
[188825423]
Results pending completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[188825424]
On (b)(6) 2020, a patient who had 4 positive at home urine hcg tests had a false negative result in the clinic on an hcg urine cassette. On the next day, the beta hcg venous blood draw result was positive. There was no patient consequences. Although requested, no further information was given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00013 |
| MDR Report Key | 9827255 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-12 |
| Model Number | FHC-102 |
| Lot Number | HCG9092050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO |
| Manufacturer Address | 9975 SUMMERS RIDGE RD SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |