Brand Name | CONTOUR NEXT |
Type of Device | QUALITY CONTROL MATERIAL |
Manufacturer (Section D) |
ASCENSIA DIABETES CARE US INC. |
430 s. beiger st. |
mishawaka IN 46544 |
|
Manufacturer (Section G) |
BAYER HEALTHCARE LLC |
430 s. beiger st. |
|
mishawaka IN 46544 |
|
Manufacturer Contact |
jeri
messmore
|
430 s. beiger st. |
mishawaka, IN 46544
|
5742567719
|
|
MDR Report Key | 4910088 |
MDR Text Key | 6834927 |
Report Number | 1826988-2015-00333 |
Device Sequence Number | 1 |
Product Code |
JJX
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K111268 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,consumer,foreign |
Reporter Occupation |
Patient
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
06/18/2015 |
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 |
Lay User/Patient
|
Device Expiration Date | 03/31/2016 |
Device Model Number | 7325 |
Device Lot Number | 3063 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/14/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/18/2015
|
Initial Date FDA Received | 07/13/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/18/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/01/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | Z-2482-2015 |
Patient Sequence Number | 1 |
|
|