MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-03-11 for MEDLINE HCG URINE CASSETTE FHC-102 manufactured by Alere San Diego.
[188841633]
Results pending completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[188841634]
Two hcg tests were interpreted by a nurse to be negative. When conferring with other nurses, some of the personnel saw a faint positive line. All results were interpreted during the read window. Because there were different interpretations of the test results, a serum sample was sent to the lab with unknown results. Although additional information was requested, no further information was able to be obtained. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00012 |
| MDR Report Key | 9818646 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-11 |
| 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 | MEDLINE HCG URINE CASSETTE |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-03-11 |
| Model Number | FHC-102 |
| Lot Number | HCG9040132 |
| 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 | 9995 SUMMERS RIDGE RD SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |