FDA Adverse Event
Malfunction
Summary report: N
TRUERESULT
MDR report key: 4200151
·
Received October 21, 2014
Report
- Report Number
- 1052693-2014-00425
- Event Type
- Malfunction
- Date Received
- October 21, 2014
- Date of Event
- September 22, 2014
- Report Date
- January 4, 2016
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K080641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT YET RETURNED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: : USER HAS LOW GLUCOSE VALUE.
Description of Event or Problem · 1
CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 6 TESTS IN MEMORY: "LO", "LO", "LO", 107MG/DL, 103MG/DL, 92MG/DL. NO ADVERSE EVENT REPORTED.
Description of Event or Problem · 1
CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO." LAST 6 TESTS IN MEMORY: "LO", "LO", "LO", 107 MG/DL, 103 MG/DL AND 02 MG/DL. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669965 | TRUERESULT | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUERESULT | PP1106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR |