FDA Adverse Event
Malfunction
Summary report: N
TRUERESULT
MDR report key: 4615701
·
Received March 12, 2015
Report
- Report Number
- 1052693-2015-00271
- Event Type
- Malfunction
- Date Received
- March 12, 2015
- Date of Event
- February 16, 2015
- Report Date
- March 12, 2015
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K080641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INTERNAL REPORT #: (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: STRIP ISSUE.
Additional Manufacturer Narrative · 1
PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". THE CUSTOMER IS KEEPING THE METER AND STRIPS IN THE KITCHEN. CUSTOMER DOES NOT FEEL ILL. CUSTOMER STATED THAT HER EXPECTED BLOOD GLUCOSE RANGE IS 120 - 150 MG/DL, PRIOR TO EATING. THE CUSTOMER IS KEEPING THE SUPPLIES IN THE KITCHEN. I PULLED LAST FIVE RESULTS FROM MEMORY; LO, (B)(6), 7:00 AM, BEFORE EATING; LO, (B)(6), 6:57 AM, BEFORE EATING; LO, (B)(6), 12:00 PM. +2 HOURS AFTER EATING; LO, (B)(6), 12:00 PM, +2 HOURS AFTER EATING; LO, (B)(6), 1:04 PM, +2 HOURS AFTER EATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171476 | TRUERESULT | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUERESULT | PP1591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |