Brand Name | TRIAGE CARDIAC PANEL, TNI/CKMB |
Type of Device | TRIAGE CARDIAC PANEL, TNI/CKMB |
Manufacturer (Section D) |
QUIDEL CARDIOVASCULAR INC. |
9975 summers ridge road |
san diego CA 92121 |
|
Manufacturer Contact |
chelsea
lindgren
|
9975 summers ridge road |
san diego, CA 92121
|
8583020294
|
|
MDR Report Key | 17193305 |
MDR Text Key | 317927551 |
Report Number | 3013982035-2023-00009 |
Device Sequence Number | 1 |
Product Code |
MMI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K030286 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
06/23/2023 |
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 Expiration Date | 08/03/2023 |
Device Model Number | 97022HS |
Device Lot Number | T13708RN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/26/2023
|
Initial Date FDA Received | 06/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/20/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | TRIAGE METERPROS PN: 55070, SN: (B)(6). |