MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2013-05-14 for HCG ONE STEP HOME PREGNANCY TEST MIDSTREAM FHC-103B-ONC02 manufactured by Alere San Diego, Inc.
[18063142]
Consumer alleged potential false negative hcg one step home pregnancy urine test results in comparison to a positive result on an unspecified name brand pregnancy test. Consumer reports that first morning urine was used on the first day of her missed menstrual cycle and the result was negative for pregnancy on the hcg one step home pregnancy urine test. On the fourth day of her missed menstrual cycle, an add'l hcg one step home pregnancy urine test was performed, which showed a negative result. The unspecified name brand pregnancy test result, which was administered within an hour of the hcg one step home pregnancy urine test, showed a positive result. The pregnancy was confirmed by her physician. There was no reported adverse pt sequela. There was no add'l info provided.
Patient Sequence No: 1, Text Type: D, B5
[18324026]
Date of incident is estimated as (b)(6) 2013, as this is the date that the mfr was made aware of event. Event reported as occurring "sometime in (b)(6)". Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2013-00387 |
| MDR Report Key | 3126299 |
| Report Source | 04,08 |
| Date Received | 2013-05-14 |
| Date of Report | 2013-05-14 |
| Date of Event | 2013-04-22 |
| Date Mfgr Received | 2013-04-22 |
| Date Added to Maude | 2013-07-22 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MGR |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCG ONE STEP HOME PREGNANCY TEST MIDSTREAM |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | LCX |
| Date Received | 2013-05-14 |
| Model Number | FHC-103B-ONC02 |
| Lot Number | HCG1120116 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-14 |