Brand Name | BENZ BENZODIAZEPINES PLUS |
Type of Device | ENZYME IMMUNOASSAY, BENZODIAZEPINE |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
ROCHE DIAGNOSTICS GMBH |
sandhoferstrasse 116 |
na |
mannheim (baden-wurttemberg) 68305 |
GM
68305
|
|
Manufacturer Contact |
michael
leslie
|
9115 hague road |
na |
indianapolis, IN 46250
|
3175214343
|
|
MDR Report Key | 7792458 |
MDR Text Key | 117446516 |
Report Number | 1823260-2018-02746 |
Device Sequence Number | 1 |
Product Code |
JXM
|
UDI-Device Identifier | 04015630997718 |
UDI-Public | 04015630997718 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043327 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/17/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/17/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 04490789190 |
Device Lot Number | 279762 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/26/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | AMLODIPINE; ASPIRIN; ATENOLOL; CLONAZEPAM; CO Q-10; CYCLOBENZAPRINE; GABAPENTIN; KRILL OIL; MULTIVITAMIN; PRAVASTIN; RELION PRIME |
Patient Age | 67 YR |
Patient Weight | 88 |