FDA Adverse Event
Malfunction
Summary report: N
TRUETRACK
MDR report key: 4110117
·
Received September 11, 2014
Report
- Report Number
- 1052693-2014-00305
- Event Type
- Malfunction
- Date Received
- September 11, 2014
- Date of Event
- July 31, 2014
- Report Date
- January 7, 2016
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K032657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER MECHANICAL STRESS.
Additional Manufacturer Narrative · 1
(B)(4). RETURNED PRODUCT SHOWS SOME LCD CHARACTERS MISSING, WHICH MAY CAUSE INCORRECT INTERPRETATION OF METER RESULTS. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: METER DROPPED/IMPACTED/STRESSED ENOUGH TO BREAK LCD.
Description of Event or Problem · 1
CONSUMER CALLED. METER LCD DISPLAY SHOWS PARTIAL CHARACTERS. NO ADVERSE EVENT REPORTED.
Description of Event or Problem · 1
CONSUMER CALLED. METER LCD DISPLAY SHOWS PARTIAL CHARACTERS. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 563261 | TRUETRACK | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUETRACK | RR4336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR |