Brand Name | TRIAGE TOTAL 5 CONTROL L1 |
Type of Device | MULTI-ANALYTE CONTROLS |
Manufacturer Contact |
ya-ling
king
|
9975 summers ridge road |
san diego, CA 92121
|
8588052084
|
|
MDR Report Key | 6230650 |
MDR Text Key | 64133215 |
Report Number | 2027969-2017-00011 |
Device Sequence Number | 1 |
Product Code |
JJY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K072892 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
Reporter Occupation |
Health Professional
|
Remedial Action |
Replace |
Type of Report
| Initial,Followup |
Report Date |
09/29/2016 |
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 | 88753 |
Device Lot Number | C3233A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/31/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/02/2017 |
Initial Date FDA Received | 01/06/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/07/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 2027969-10/12/16-004-C |
Patient Sequence Number | 1 |
Treatment | TRIAGE BNP PANEL, PN 98000XR, LOT# W61813B; TRIAGE METERPRO DOMESTIC KIT, PN 55071AR, SN (B)(4 |
|
|