FDA Adverse Event
Other
Summary report: N
TRUERESULT
MDR report key: 3472032
·
Received November 4, 2013
Report
- Report Number
- 1052693-2013-00138
- Event Type
- Other
- Date Received
- November 4, 2013
- Date of Event
- April 16, 2013
- Report Date
- June 28, 2013
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K080710
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COMMUNICATIONS TO CUSTOMER (PHONE, MAIL) WERE NOT RETURNED. UNABLE TO GET PRODUCT BACK OR OBTAIN MORE INFO.
Description of Event or Problem · 1
RECEIVED INITIAL EMAIL FROM (B)(6) CLAIMS MANAGEMENT COMPANY THAT A CUSTOMER (B)(6) HAS FILED A CLAIM FOR MEDICAL ATTENTION HE NEEDED IN (B)(6) 2012, DUE TO A METER AND TEST STRIPS DISPLAYING INCORRECT READINGS. CUSTOMER DID SEEK MEDICAL ATTENTION AT THE HOSPITAL. NO FURTHER INFO RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565842 | TRUERESULT | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUERESULT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |