FDA Adverse Event
Malfunction
Summary report: N
BLOOD GLUCOSE SYSTEM
MDR report key: 5128160
·
Received October 5, 2015
Report
- Report Number
- 1052693-2015-01890
- Event Type
- Malfunction
- Date Received
- October 5, 2015
- Date of Event
- September 14, 2015
- Report Date
- October 5, 2015
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K080641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 75-115MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 02/25/2017. TEST STRIP STORAGE WAS NOT DISCLOSED, VIAL OF STRIPS WERE OPENED A YEAR AGO. REVIEWED METER MEMORY: (B)(6). CUSTOMER WAS CONCERN WITH RESULTS TAKEN ON (B)(6) 2015 47 MG/DL (NOT FASTING). NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 658070 | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUERESULT | PR1974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR | SECOND THERAPY |