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 ACCEAVA HCG BASIC II 92208 (FHC-102) manufactured by Innovacon, Inc..
[801788]
Called nurse - she said she works in er dept. She has had several of her nurses tell her that they got a false negative hcg result with the test. They tried testing some pts from labor and delivery and all tests were negative. She took the lot number out of the use and stopped using it. She said she was too busy to talk and give add'l info. It is not known if test procedure from product instruction was followed. The efforts to have unused devices returned were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[8043327]
Retention device testing performed. The retention devices meet qc spec. Correct positive results were observed when tested with 25miu/ml hcg urine control. The 100miu/ml, 10iu/ml and 213. 2iu/ml hcg urine control yielded clearly positive results at 3 mins reading time. Probable root cause: the urine hcg level always lower than serum as the urine sample is more likely influenced by many factors. If the pt drinks too much water which will dilute the urine before the test, the urine may not contain representative levels of hcg and a false negative result may be obtained. As so, if pregnancy is suspected, a first morning urine specimen should be collected and tested. Conclusion: the retension strips meet qc spec. No false negative result was observed. This complaint is not confirmed. Mfg documentation for this lot number was reviewed. No abnormality had been observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005689981-2008-00010 |
| MDR Report Key | 1006621 |
| Report Source | 05 |
| Date Received | 2008-03-04 |
| Date of Report | 2008-02-29 |
| Date of Event | 2006-02-13 |
| Date Mfgr Received | 2008-02-13 |
| Date Added to Maude | 2008-06-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | ACCEAVA HCG BASIC II |
| Generic Name | ONE STEP PREGNANCY TEST (URINE) |
| Product Code | JHJ |
| Date Received | 2008-03-04 |
| Model Number | 92208 (FHC-102) |
| Lot Number | HCG7060200 |
| 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 | 1005125 |
| Manufacturer | INNOVACON, INC. |
| Manufacturer Address | 4106 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-04 |