MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-17 for CHOLESTEROL TEST manufactured by Advanced Care Products.
[21246996]
The unit is sold for one determination of total blood cholesterol. The unit has no controls. The only assurance of 97% accuracy as stated by the company is the company's word. The rptr questions how one can know if the test is accurate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003705 |
| MDR Report Key | 16865 |
| Date Received | 1994-10-17 |
| Date of Report | 1994-10-13 |
| Date Added to Maude | 1994-10-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTEROL TEST |
| Product Code | CGO |
| Date Received | 1994-10-17 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16798 |
| Manufacturer | ADVANCED CARE PRODUCTS |
| Manufacturer Address | RARITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-10-17 |