FDA Adverse Event
Injury
Summary report: N
IBGSTAR BGMS
MDR report key: 3001617
·
Received March 11, 2013
Report
- Report Number
- 3004637226-2013-00005
- Event Type
- Injury
- Date Received
- March 11, 2013
- Report Date
- March 11, 2013
- Manufacturer
- AGAMATRIX, INC.
- Product Code
- NBW
- PMA / PMN Number
- K103544
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER CALLED WITH A COMPLAINT ABOUT THE IBGSTAR METER. THE CUSTOMER SAID SHE/HE HAD TO CALL 911 BECAUSE SHE FELT SHE/HE WAS GOING TO PASS OUT. SHE/HE TOOK HIS/HER BLOOD TEST AND IT SAID 459. SHE/HE GAVE THEMSELVES INSULIN. THE PARAMEDICS ARRIVED AND TOOK A BLOOD TEST WITH THEIR METER WITHIN 10 MINS OF THE ORIGINAL TEST AND THEIR METER READ 57. AFTER SHE/HE STARTED FEELING BETTER I TOOK IT ON THE IBG STAR METER AND IT READ 113. THE PARAMEDICS DID ANOTHER TEST WITH THE SAME FINGER THAT SHE/HE JUST TESTED AND IT SAID 221.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101648 | IBGSTAR BGMS | BLOOD GLUCOSE METER | NBW | AGAMATRIX, INC. | 8000-04944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |