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 2020-02-07 for CONSULT HCG URINE CASSETTE 5001 25T FHC-A102 manufactured by Alere San Diego.
[188841483]
Results pending completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[188841484]
The distributer reported that a women's health facility had false negative results on the hcg urine cassette initially providing a lot number. For one patient, the result for four tests with one specimen was 2 false positive results and 2 negative results with a negative serum test result. Subsequent contact with the customer revealed that the customer could not actually identify which lot number was used when the inaccurate results were obtained. The customer was not willing to provide additional details but would send the product back. On 01/22/2020, lot numbers hcg9072026, hcg9040123, hcg9040084 were received. It is still unknown which lot was used at the time of the events. For this reason, one mdr will report this event. This mdr is associated with 2027969-2020-0009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00010 |
| MDR Report Key | 9684778 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-07 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2020-02-07 |
| 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 ROAD |
| 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 | CONSULT HCG URINE CASSETTE 5001 25T |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2020-03-23 |
| Model Number | FHC-A102 |
| 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 |
| Manufacturer Address | 9995 SUMMERS RIDGE RD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |