FDA Adverse Event
Malfunction
Summary report: N
BLOOD GLUCOSE SYSTEM
MDR report key: 5053953
·
Received September 3, 2015
Report
- Report Number
- 1052693-2015-01610
- Event Type
- Malfunction
- Date Received
- September 3, 2015
- Date of Event
- August 11, 2015
- Report Date
- September 3, 2015
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K080641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- 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 LO RESULTS. CUSTOMER STATES SHE FEELS WELL AND NO MEDICAL ATTENTION IS NEEDED. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 65-199MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 08/13/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST LO AND LO. REVIEWED METER MEMORY: 1:LO (B)(6) 2015 05:05:00 PM FASTING:YES, 2:LO (B)(6) 2015 05:06:00 PM FASTING:NO, 3:LO (B)(6) 2015 05:08:00 PM FASTING:YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584624 | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUERESULT | PR2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR | SECOND THERAPY |