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 2020-02-13 for CONSULT HCG URIN/SRM COMBO 5002 25 FHC-A202 manufactured by Alere San Diego, Inc..
[188845289]
: devices not returned. Customer to monitor - troubleshooting provided. Results pending investigation.
Patient Sequence No: 1, Text Type: N, H10
[188845290]
(b)(6) 2020: patient contacted facility after obtaining a positive result on a home pregnancy test (unspecified brand/specificity) and passing some tissue. Date home pregnancy test was performed is unknown. Patient was advised to come into the facility. Patient urine sample was tested on the consult hcg combo cassette and a negative result was obtained. The urine specimen was not quantified. The facility performed a confirmatory blood test which provided a positive result of 268 miu/ml. All tests were performed on the same day but the exact times were not provided. The facility then performed an ultrasound on the same day, which revealed the patient has experienced a miscarriage. Customer states miscarriage was spontaneous in nature. No treatment was provided or withheld based on the false negative result obtained on the consult hcg combo cassette. Customer states they have three different lots at their facility, but was unable to identify which lot was used for the test. The following lots were in use at the facility: hcg9082045, hcg9082044, hcg8100020. Situations in which a patient experiences a miscarriage following a false negative hcg result will be considered limited such that the miscarriage is natural and not caused by the administration of any medications or interventions. Based on fda's guidance for "instructions for completing form fda 3500": for cases describing fetal death, miscarriage or abortion, the mother is the patient in the report (section a). Do not check "death" as an outcome attributed to the adverse event if a fetus is aborted because of a congenital anomaly (birth defect), or is miscarried. Based on the above guidance and instructions, this event is not mdr reportable as a death event. Only one mdr is being filed as there was only one event and the lot in use is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00003 |
| MDR Report Key | 9706804 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-02-13 |
| 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 | CONSULT HCG URIN/SRM COMBO 5002 25 |
| Generic Name | PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-02-13 |
| Model Number | FHC-A202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-13 |