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 2020-03-17 for MEDLINE HCG COMBO CASSETTE FHC-A202 manufactured by Alere San Diego, Inc..
[188824868]
Devices not returned. Customer to monitor - troubleshooting provided. Results pending investigation.
Patient Sequence No: 1, Text Type: N, H10
[188824869]
Unspecified date: false positive result on the medline hcg combo cassette kit. Immunoassay provided a negative result. Exact result not provided. No further information provided. Although further information was requested, no further information was able to be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00014 |
| MDR Report Key | 9842843 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 8052506 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE HCG COMBO CASSETTE |
| Generic Name | PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-03-17 |
| Model Number | FHC-A202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |