FDA Adverse Event
Death
Summary report: N
TRUTRACK
MDR report key: 2340345
·
Received November 14, 2011
Report
- Report Number
- 1052693-2011-00062
- Event Type
- Death
- Date Received
- November 14, 2011
- Date of Event
- October 17, 2011
- Report Date
- November 14, 2011
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- CGA
- PMA / PMN Number
- K032657
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
COMPLAINT OF INACCURATE RESULTS REPORTED BY A CONSUMER THROUGH (B)(6) PHARMACY. CONSUMER'S RELATIVE CLAIMS INACCURATE RESULTS LED TO IMPROPER MEDICATION RESULTING IN DEATH. PT WAS A TYPE I DIABETIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUTRACK | BLOOD GLUCOSE SYSTEM | CGA | NIPRO DIAGNOSTICS, INC. | TRUETRACK | RM3539 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |