FDA Adverse Event
Malfunction
Summary report: N
TRUETRACK
MDR report key: 4859387
·
Received June 18, 2015
Report
- Report Number
- 1052693-2015-00931
- Event Type
- Malfunction
- Date Received
- June 18, 2015
- Date of Event
- May 22, 2015
- Report Date
- June 18, 2015
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- CGA
- PMA / PMN Number
- K032657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 100-150MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/22/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER RAN A BACK TO BACK BLOOD TEST HI AND HI. REVIEWED METER MEMORY: HI (B)(6) 2015 11:31:00 AM FASTING: YES; HI (B)(6) 2015 03:50:00 AM FASTING: YES; HI (B)(6)2015 08:28:00 PM FASTING: YES; 562MG/DL (B)(6) 2015 04:33:00 PM FASTING: YES; 566MG/DL (B)(6) 2015 04:26:00 PM FASTING: YES. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398605 | TRUETRACK | BLOOD GLUCOSE SYSTEM | CGA | NIPRO DIAGNOSTICS, INC. | TRUETRACK | RS4580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |