MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-04 for GENERIC HCG URINE CASSETTE FHC-102 manufactured by Innovacon, Inc..
[22081241]
Received email. Description of reported problem: pregnancy tests are yielding false results. One patient is 6 weeks pregnant and received a negative test result. No additional information avaliable.
Patient Sequence No: 1, Text Type: D, B5
[22115379]
Summary of results: the retention devices met qc specification. Correct negative results were obtained when tested with negative urine sample. Correct positive results were found when tested with 25 miu/ml hcg 100 miu/ml and 10 iu/ml hcg urine control. Clear positive result was observed when tested with 208. 99 iu/ml hcg clinic urine control. Conclusion: from our testing, all the results were fine. So the complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005689981-2008-00012 |
| MDR Report Key | 1006619 |
| Report Source | 05 |
| Date Received | 2008-03-04 |
| Date of Report | 2008-02-29 |
| Date of Event | 2008-02-15 |
| Date Mfgr Received | 2008-02-15 |
| Date Added to Maude | 2008-05-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4106 SORRENTO VALLEY BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582008910 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENERIC HCG URINE CASSETTE |
| Generic Name | ONE STEP PREGNANCY TEST (URINE) |
| Product Code | JHJ |
| Date Received | 2008-03-04 |
| Model Number | FHC-102 |
| Lot Number | HCG6030312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1005487 |
| Manufacturer | INNOVACON, INC. |
| Manufacturer Address | 4106 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-04 |