Brand Name | TOTAL BILIRUBIN |
Type of Device | DIAZO COLORIMETRY, BILIRUBIN |
Manufacturer (Section D) |
ABBOTT LABORATORIES |
1915 hurd drive |
irving TX 75038 |
|
Manufacturer (Section G) |
ABBOTT LABORATORIES |
1915 hurd drive |
|
irving TX 75038 |
|
Manufacturer Contact |
christian
lee
|
100 abbott park road |
dept. 09b9, lc cp01-3 |
abbott park, IL 60064-3537
|
2246682940
|
|
MDR Report Key | 10838627 |
MDR Text Key | 230510681 |
Report Number | 3016438761-2020-00299 |
Device Sequence Number | 1 |
Product Code |
CIG
|
UDI-Device Identifier | 00380740011369 |
UDI-Public | 00380740011369 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K121985 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/13/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2021 |
Device Model Number | 6L45-21 |
Device Catalogue Number | 06L45-21 |
Device Lot Number | 56889UQ02 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/27/2020 |
Initial Date FDA Received | 11/13/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/02/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |