MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2004-09-10 for BD PARADIGM LINK GLUCOSE MONITOR 322201 manufactured by Becton Dickinson.
[36097149]
Awaiting product return to conduct quality investigation.
Patient Sequence No: 1, Text Type: N, H10
[36097150]
Consumer called to report his meter is giving inaccurate readings. Analysis run on clark error grid using mean avg. Reading (62) as ref. Point vs. Bd readings (25, 99) yielded data points in the d range of the grid, outside of acceptable limits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2004-00544 |
| MDR Report Key | 5351791 |
| Report Source | CONSUMER |
| Date Received | 2004-09-10 |
| Date of Report | 2004-09-10 |
| Date of Event | 2004-08-11 |
| Date Mfgr Received | 2004-08-11 |
| 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 |
| Device Expiration Date | 2005-10-01 |
| 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 |