FDA Adverse Event
Malfunction
Summary report: N
TRUETRACK
MDR report key: 4961254
·
Received July 30, 2015
Report
- Report Number
- 1052693-2015-01296
- Event Type
- Malfunction
- Date Received
- July 30, 2015
- Date of Event
- July 3, 2015
- Report Date
- July 29, 2015
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- CGA
- PMA / PMN Number
- K032657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PRODUCT NOT YET RETURNED FOR EVAL.
Description of Event or Problem · 1
CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 300-350MG/DL FASTING. VERIFIED THE STRIPS EXPIRE ON 05/14/2015 AND HAS BEEN STORING THE STRIPS IN THE KITCHEN. REVIEWED METER MEMORY: HI (B)(6) 2015 12:35:00 PM FASTING: YES; HI (B)(6) 2015 12:34:00 PM FASTING: YES; HI (B)(6) 2015 12:33:00 PM FASTING: YES; 293MG/DL (B)(6) 2015 11:09:00 PM FASTING: YES; 131MG/DL (B)(6) 2015 01:59:00 AM FASTING: YES. CUSTOMERS CONCERN: WITH HI (B)(6) 2015 12:35PM. ADVERSE EVENT NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498160 | TRUETRACK | BLOOD GLUCOSE SYSTEM | CGA | NIPRO DIAGNOSTICS, INC. | TRUETRACK | RN4062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |