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 2020-01-07 for FISHER-SURE-VUE HCG-STAT SRM/URINE (30T) FHC-A202 23900530 manufactured by Alere San Diego, Inc..
[188854541]
Results pending investigation.
Patient Sequence No: 1, Text Type: N, H10
[188854542]
(b)(6) 2019: patient presented to the facility for a laparoscopic bilateral salpingectomy. Patient urine was tested on the fisher sure-vue hcg stat serum/urine kit by a new technician and at 3 minutes, a negative result was obtained. The technician took a second look at the cassette before the 4 minute read time and the technician observed a faint positive result. The surgery was delayed based on the false positive result. A quantitative serum hcg test was performed and the result was negative at <1. 2 miu/ml. The customer was unable to state how long the surgery was delayed, however, she believes the surgery was performed the same day. The procedure was not emergent; it was a scheduled procedure. No adverse patient outcomes reported. Troubleshooting was performed focusing on possible causes such as deviations in storage, technique, handling and patient specimen factors as specified in the corresponding package insert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00001 |
| MDR Report Key | 9558438 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-01-07 |
| 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 (30T) |
| Generic Name | PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-01-07 |
| Returned To Mfg | 2020-01-13 |
| Model Number | FHC-A202 |
| Catalog Number | 23900530 |
| Lot Number | HCG9050160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-07 |