MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-03-04 for HENRY SCHEIN ONE STEP + HCG DIPSTICK FHC-101-KHS25 manufactured by Innovacon, Inc..
[784176]
In 2008, a woman did an ept test and the result was positive. Lauren had this woman collect a urine specimen around 2 pm and lauren tested this specimen on henry schein urine hcg rapid dipstick test. Result was negative. The woman went to her ob/gyn that same day around 6 pm where they did a urine test (result positive) and a serum test (result positive). It was unknown if it was a serum qualitative or quantitative that was performed. Qc is working fine and seeing a control line with each...
Patient Sequence No: 1, Text Type: D, B5
[7951264]
Retention device testing performed. The retention devices meet qc specification. Correct positive results were observed when tested with 25 miu/ml hcg urine control. The 100 miu/ml 10 iu/ml and 213. 2 iu/ml hcg urine control yielded clearly positive results at 3 minutes 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 patient 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 results may be obtained. As so, if pregnancy is suspected, a first morning urine specimen should be collected and tested. Conclusion: this complaint is not confirmed. Manufacturing documentation for this lot number was review. No abnormality had been observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005689981-2008-00013 |
| MDR Report Key | 1006618 |
| Report Source | 05,08 |
| Date Received | 2008-03-04 |
| Date of Report | 2008-02-29 |
| Date of Event | 2008-01-11 |
| Date Mfgr Received | 2008-02-07 |
| 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 | HENRY SCHEIN ONE STEP + HCG DIPSTICK |
| Generic Name | ONE STEP PREGNANCY TEST (URINE) |
| Product Code | JHJ |
| Date Received | 2008-03-04 |
| Model Number | FHC-101-KHS25 |
| Lot Number | HCG7090098 |
| 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 | 1005451 |
| Manufacturer | INNOVACON, INC. |
| Manufacturer Address | 4106 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-04 |