MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-10 for BD PARADIGM LINK GLUCOSE MONITOR 322201 manufactured by Becton Dickinson.
[36482021]
Awaiting product return to conduct quality investigation.
Patient Sequence No: 1, Text Type: N, H10
[36482022]
Consumer called to report high and low readings w/her meter. Analysis run on clark error grid using mean avg. Reading (67) as ref. Point vs. Bd readings (30, 104) yielded data points in the d range of the grid, outside of acceptable limits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2004-00547 |
| MDR Report Key | 5351802 |
| Date Received | 2004-09-10 |
| Date of Report | 2004-09-10 |
| Date of Event | 2004-08-12 |
| Date Mfgr Received | 2004-08-12 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2016-01-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SALLY THOMSON |
| Manufacturer Street | 1 BECTON DR. |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018474838 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD PARADIGM LINK GLUCOSE MONITOR |
| Generic Name | BD TEST STRIPS |
| Product Code | FJD |
| Date Received | 2004-09-10 |
| Model Number | NA |
| Catalog Number | 322201 |
| Lot Number | 3064100 |
| ID Number | NA |
| Device Expiration Date | 2005-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DR. FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-10 |