MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-10 for CHOLESTRAK * 80202 manufactured by Accu Tech.
[292838]
Caller followed directions on box. When they attempted to use the lancet to obtain a blood sample they pushed against finger, but no needle came out of device. The kit comes with 2 needles, and caller had the same problem with the 2nd lancet. Caller notified help line as per directions. Left message, and someone called back. The help line offered to replace kit and stated they would include 2 old lancets along with the new lancet to ensure device would work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029469 |
| MDR Report Key | 484054 |
| Date Received | 2003-09-10 |
| Date of Report | 2003-09-10 |
| Date of Event | 2003-09-09 |
| Date Added to Maude | 2003-09-23 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | CHOLESTRAK |
| Generic Name | HOME CHOLESTEROL TESTING KIT |
| Product Code | NFX |
| Date Received | 2003-09-10 |
| Model Number | * |
| Catalog Number | 80202 |
| Lot Number | 03P0242 |
| ID Number | * |
| Device Expiration Date | 2005-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 472940 |
| Manufacturer | ACCU TECH |
| Manufacturer Address | 2641 LA MIRADA DRIVE VISTA CA 92083 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-09-10 |