MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-12 for FISHER - SURE-VUE HCG URINE CASS. (30T) FHC-A202 23900531 manufactured by Alere San Diego.
[188826310]
Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples. The results were read at 3 and 4 minutes, and all devices yielded the expected negative results. No false positive results were observed during in-house testing. The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified. Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications. Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified. A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product. Per the package insert, this test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
Patient Sequence No: 1, Text Type: N, H10
[188826311]
The customer reported that an rn checked the hcg test result after 3 minutes observing a false positive result. A control line was present with a clear line in the test region and a pink background. A second urine pregnancy test was done with a negative result. A blood sample tested at a lab confirmed results to be negative for pregnancy. This file is associated with 2027969-2020-00007.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00006 |
| MDR Report Key | 9827532 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-24 |
| 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 | FISHER - SURE-VUE HCG URINE CASS. (30T) |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-03-12 |
| Model Number | FHC-A202 |
| Catalog Number | 23900531 |
| Lot Number | HCG9072032 |
| 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 | 9975 SUMMERS RIDGE RD SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |