Brand Name | HDL-CHOLESTEROL GEN.4 |
Type of Device | HIGH DENSITY LIPOPROTEIN TEST SYSTEM |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 0457 |
|
MDR Report Key | 10829397 |
MDR Text Key | 215932250 |
Report Number | 1823260-2020-02858 |
Device Sequence Number | 1 |
Product Code |
LBS
|
Combination Product (y/n) | N |
PMA/PMN Number | K162593 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
12/01/2020 |
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 Model Number | HDL-C G4 |
Device Catalogue Number | 07528582190 |
Device Lot Number | 41422801 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/23/2020 |
Initial Date FDA Received | 11/12/2020 |
Supplement Dates Manufacturer Received | 10/23/2020
|
Supplement Dates FDA Received | 12/01/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | CHELAZINC; FENOFIBRATE; GLI-PIZIDE; LOSARTAN; METFORMIN; MINOXIDIL5%,; VIT. D2; YASMIN; CHELAZINC; FENOFIBRATE; GLI-PIZIDE; LOSARTAN; METFORMIN; MINOXIDIL5%,; VIT. D2; YASMIN |
|
|