FDA Adverse Event
Injury
Summary report: N
PRESTO KROGER BGMS
MDR report key: 3767250
·
Received April 4, 2014
Report
- Report Number
- 3004637226-2014-00014
- Event Type
- Injury
- Date Received
- April 4, 2014
- Report Date
- April 3, 2014
- Manufacturer
- AGAMATRIX, INC.
- Product Code
- NBW
- PMA / PMN Number
- K073573
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF BOTH THE OWNER'S GUIDE AND SIMILAR COMPLAINTS WAS PERFORMED. THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFO PROVIDED.
Description of Event or Problem · 1
KROGER METER PRODUCED A BLOOD-GLUCOSE RESULT OF 147 MG/DL. BASED ON THAT TOOK MEDICINE BUT EXHIBITED SYMPTOMS OF HYPOGLYCEMIA. DURING THE EVENT, THE METER READ 81 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205380 | PRESTO KROGER BGMS | BLOOD GLUCOSE METER | NBW | AGAMATRIX, INC. | 8000-04166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |