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 2019-11-22 for ALERE HCG CASSETTE 92210 manufactured by Alere San Diego, Inc..
[188832688]
Results pending investigation.
Patient Sequence No: 1, Text Type: N, H10
[188832689]
(b)(6) 2019: a (b)(6) female patient visited clinic for an hcg test. Patient urine was collected at unknown time and was tested using the alere hcg cassette at unknown time. A positive result was obtained on the alere hcg cassette at the 3 minute read time. Patient sample was drawn same day at an unknown time and was sent for confirmatory testing on the dxi beckman 800. The quantitative hcg provided a result of <1 mlu/ml although further information was requested, no further information was provided by the customer. Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi)-no deviations noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00604 |
| MDR Report Key | 9365619 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2019-11-14 |
| Date Added to Maude | 2019-11-22 |
| 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 | ALERE HCG CASSETTE |
| Generic Name | PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2019-11-22 |
| Model Number | 92210 |
| Lot Number | HCG9030081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-11-22 |