Brand Name | FREESTYLE LIBRE 14 DAY SYSTEM SENSOR |
Type of Device | SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED |
Manufacturer (Section D) |
ABBOTT DIABETES CARE INC. |
|
|
MDR Report Key | 15906127 |
MDR Text Key | 304867386 |
Report Number | MW5113581 |
Device Sequence Number | 1 |
Product Code |
QLG
|
UDI-Device Identifier | 57519080000 |
UDI-Public | 57519-0800-00 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
11/29/2022 |
4 Devices were Involved in the Event: |
1
2
3
4
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/01/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/20/2023 |
Device Lot Number | T60000490 |
Was Device Available for Evaluation? |
Yes
|
Patient Sequence Number | 1 |
Treatment | POTASSIUM, CLARITIN.; VALSARTAN, VOTRIENT, PACLITAXEL, ZOFRAN, DIPHENHYDRAMINE, TRESIBA, HUMALOG, CRESTOR, NEXIUM, SINGULAIR. |
Patient Outcome(s) |
Other;
|
Patient Age | 63 YR |
Patient Sex | Male |
Patient Weight | 166 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|