FDA Adverse Event
Malfunction
Summary report: N
BLOOD GLUCOSE SYSTEM
MDR report key: 5145156
·
Received October 13, 2015
Report
- Report Number
- 1052693-2015-01965
- Event Type
- Malfunction
- Date Received
- October 13, 2015
- Date of Event
- September 22, 2015
- Report Date
- October 12, 2015
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K032657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 HI RESULTS. CUSTOMER'S WIFE STATES HER HUSBAND FELT LIKE HE HAD NO ENERGY AND WAS ILL BUT IS CURRENTLY FEELING FINE. CUSTOMER STATES THE THAT NOT MEDICAL ATTENTION IS REQUIRED BUT THAT HE MAY SEEK MEDICAL ATTENTION LATER. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-130MG/DL NOT FASTING. VERIFIED THE STRIPS EXPIRE 10/14/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: (B)(6). CUSTOMERS CONCERN: HI (B)(6) 9:00PM , HI (B)(6) 8:58PM , HI (B)(6) 8:55PM , HI (B)(6) 4:44PM & HI (B)(6) 4:42PM. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676858 | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUETRACK | RS4652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR | SECOND THERAPY |