FDA Adverse Event
Malfunction
Summary report: N
TRUERESULT
MDR report key: 4924414
·
Received July 16, 2015
Report
- Report Number
- 1052693-2015-01206
- Event Type
- Malfunction
- Date Received
- July 16, 2015
- Date of Event
- June 23, 2015
- Report Date
- July 16, 2015
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- LFR
- PMA / PMN Number
- K080641
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).
Description of Event or Problem · 1
CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. "(B)(6)" CALLED ON BEHALF OF THE CUSTOMER AND STATES THE CUSTOMER IS UNABLE TO PERFORM A BLOOD TEST DUE TO AN ERROR 4 MESSAGE. "LUIS" STATES THAT THE CUSTOMER HAS A HEADACHE AND DOES NOT FEEL WELL. THE CUSTOMER WILL SEEK MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 200-250 MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/19/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 1: 182 MG/DL, (B)(6) 2015, 11:26:00 PM, FASTING: YES; 2: 272 MG/DL, (B)(6) 2015, 12:20:00 AM, FASTING: YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463694 | TRUERESULT | BLOOD GLUCOSE SYSTEM | LFR | NIPRO DIAGNOSTICS, INC. | TRUERESULT | PR2168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |