FDA Adverse Event
Malfunction
Summary report: N
TRIAGE PROFILER SHORTNESS OF BREATH PANEL
MDR report key: 1203754
·
Received October 9, 2008
Report
- Report Number
- 2027969-2008-00026
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- September 7, 2008
- Report Date
- October 8, 2008
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- MMI
- PMA / PMN Number
- K042723
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT SUPPORT (PS) TESTED RETURNED, AND RETAINED DEVICES. PS DID NOT OBSERVE HIGH OUTLIERS DURING CALIBRATORS AND WHOLE BLOOD TESTING. PS DID NOT CONFIRM THE CLIENT'S OBSERVATIONS WITH IN-HOUSE TESTING. CUSTOMER COMPLAINT COULD NOT BE DIRECTLY CONFIRMED FOR LACK OF SPECIMEN. TESTING WITH RETAINED PRODUCT INDICATED NO OUTLIER RESULTS TO, WHICH THE FALSE POSITIVE TNI RESULT COULD BE ATTRIBUTED. BATCH RECORD REVIEW INDICATED SINGLE POINT OUTLIERS ON EACH OF 2 DAYS WHEN NON-DISEASED PATIENT WHOLE BLOOD WAS EXAMINED. DEFICIENCY ESTABLISHED. RELEASE SPECIFICATION EVALUATION PENDING.
Description of Event or Problem · 1
FALSE POSITIVE TROPONIN I (TNI) RESULTS OF 0.06 NG/ML ON 2ND OF 5 SERIAL DRAWS FOR ONE PATIENT. NO FURTHER INFO PROVIDED ON PATIENT DIAGNOSIS OR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE PROFILER SHORTNESS OF BREATH PANEL | CARDIAC MARKER TEST | MMI | BIOSITE INCORPORATED | 97300 | W43020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |