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 MEDLINE HCG URINE DIPSTICK FHC-101 manufactured by Alere San Diego.
[188827068]
Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified. 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. Retain testing and manufacturing record review could not be performed as a lot number could not be obtained. No information regarding technique, storage, or handling could be obtained. A root cause could not be determined due to insufficient information. Complaints are tracked and trended on a monthly basis. Per the package insert, false negative results may occur when the levels of hcg are below the sensitivity level of the test. Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
Patient Sequence No: 1, Text Type: N, H10
[188827069]
Three hcg tests read negative with the same lot number. When the patients performed drug store hcg tests the same day, they received positive results. No adverse event was reported and no other information is available although requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00008 |
| MDR Report Key | 9827513 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-21 |
| 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 | MEDLINE HCG URINE DIPSTICK |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-03-12 |
| Model Number | FHC-101 |
| 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 |