FDA Adverse Event
Malfunction
Summary report: N
FFRCT
MDR report key: 8030198
·
Received November 1, 2018
Report
- Report Number
- 3011276938-2018-00007
- Event Type
- Malfunction
- Date Received
- November 1, 2018
- Date of Event
- September 23, 2018
- Report Date
- November 1, 2018
- Manufacturer
- HEARTFLOW, INC.
- Product Code
- PJA
- UDI-DI
- 00853341006015
- PMA / PMN Number
- K161772
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
DURING AN INTERNAL REVIEW PROCESS, HEARTFLOW IDENTIFIED A DIFFERENT RESULT THAN THAT WHICH WAS ORIGINALLY PROVIDED AND INFORMED THE ORDERING PHYSICIAN ON (B)(6) 2018. THE INVESTIGATION FOR HEARTFLOW ID CASE# (B)(4) IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT. THE SECOND ANALYSIS IDENTIFIES A DIFFERENT RESULT THAN THAT WHICH WAS ORIGINALLY PROVIDED AND MAY BE OF CLINICAL IMPORTANCE. WHILE HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT, ON (B)(6) 2018, THE PHYSICIAN ACKNOWLEDGES THE COMMUNICATION ON THE SAME DAY AND REPORTS THE PATIENT HAS SINCE HAD A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE AND IS REPORTEDLY "FINE".
Description of Event or Problem · 1
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 870956 | FFRCT | HEARTFLOW FFRCT | PJA | HEARTFLOW, INC. | FFRCT 2.24 | 00853341006015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |