Brand Name | ALINITY C MAGNESIUM REAGENT KIT |
Type of Device | PHOTOMETRIC METHOD, MAGNESIUM |
Manufacturer (Section D) |
ABBOTT GMBH |
max-planck-ring 2 |
wiesbaden 65205 |
GM 65205 |
|
MDR Report Key | 12258613 |
MDR Text Key | 264477067 |
Report Number | 3002809144-2021-00459 |
Device Sequence Number | 1 |
Product Code |
JGJ
|
UDI-Device Identifier | 00380740121839 |
UDI-Public | 00380740121839 |
Combination Product (y/n) | N |
PMA/PMN Number | K181748 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup |
Report Date |
08/19/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/02/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/17/2022 |
Device Model Number | 08P1920 |
Device Catalogue Number | 08P19-30 |
Device Lot Number | 04149UN21 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 08/19/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ALNTY C PROCESSING MODU, 03R67-01, AC02158; ALNTY C PROCESSING MODU, 03R67-01, AC02158; ALNTY C PROCESSING MODU, 03R67-01, AC02158 |
|
|