Brand Name | TRUEBALANCE |
Type of Device | BLOOD GLUCOSE SYSTEM |
Manufacturer (Section D) |
NIPRO DIAGNOSTICS, INC. |
2400 n.w. 55th ct. |
fort lauderdale FL 33309 |
|
Manufacturer Contact |
karen
devincent
|
2400 n.w. 55th ct. |
fort lauderdale, FL 33309
|
9546779201
|
|
MDR Report Key | 4080486 |
MDR Text Key | 4744228 |
Report Number | 1052693-2014-00185 |
Device Sequence Number | 1 |
Product Code |
CGA
|
Combination Product (y/n) | N |
PMA/PMN Number | K080641 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Not Applicable
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
06/24/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/24/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | TRUEBALANCE |
Device Catalogue Number | H4H01-81 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 09/23/2013 |
Date Manufacturer Received | 09/13/2013 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|