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 2020-01-14 for FISHER-SURE-VUE HCG STAT SRM/URINE FHC-A202 manufactured by Alere San Diego, Inc..
[188855795]
Results pending investigation.
Patient Sequence No: 1, Text Type: N, H10
[188855797]
(b)(6) 2020: a (b)(6) female patient visited the outpatient clinic. Customer has no information on reason for visit. Urine was collected and tested positive 2x on the fisher sure-vue hcg stat serum/urine kit. Patient was sent for confirmatory serum testing at the lab and results were negative. Customer unable to provide exact confirmatory test result. No negative patient outcome reported. No treatment was provided based on the false positive results. Patient was determined to not be pregnant based on confirmatory test result. Technical services specialist reviewed the limitations section of the package insert (pi) with the customer with an emphasis on possible causes for false positive results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00002 |
| MDR Report Key | 9587181 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-14 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-01-14 |
| 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 RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052506 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FISHER-SURE-VUE HCG STAT SRM/URINE |
| Generic Name | PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-01-14 |
| Model Number | FHC-A202 |
| Lot Number | HCG9050161 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |