Brand Name | TOTAL BILIRUBIN |
Type of Device | DIAZO COLORIMETRY, BILIRUBIN |
Manufacturer (Section D) |
ABBOTT LABORATORIES |
1915 hurd drive |
irving TX 75038 |
|
MDR Report Key | 10786914 |
MDR Text Key | 239617699 |
Report Number | 3016438761-2020-00283 |
Device Sequence Number | 1 |
Product Code |
CIG
|
UDI-Device Identifier | 00380740011369 |
UDI-Public | 00380740011369 |
Combination Product (y/n) | N |
PMA/PMN Number | K121985 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup,Followup |
Report Date |
01/26/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/04/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2021 |
Device Model Number | 6L45-21 |
Device Catalogue Number | 06L45-21 |
Device Lot Number | 56326UQ11 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 01/26/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ARC C16K PRC MOD, 03L77-01, C1601273; ARC C16K PRC MOD, 03L77-01, C1601273; ARC C16K PRC MOD, 03L77-01, C1601273 |
|
|