FDA Adverse Event
Injury
Summary report: N
CONTOUR
MDR report key: 3262808
·
Received February 11, 2013
Report
- Report Number
- 1826988-2013-00026
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- January 1, 2013
- Report Date
- January 14, 2013
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- PMA / PMN Number
- K062058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INITIAL REPORTER PHONE AND ADDRESS WERE NOT PROVIDED.
Description of Event or Problem · 1
THE ADVOCATE STATED HIS FRIEND HAD RECEIVED BLOOD GLUCOSE READINGS OF 115, 110, 134 MG/DL FROM HIS CONTOUR METER BUT HE WAS FEELING VERY ILL SO AN AMBULANCE WAS CALLED. AN HOUR LATER AMBULANCE PERSONNEL RAN A BLOOD TEST ON THE CUSTOMER AND THE READING WAS 490 MG/DL. THE CUSTOMER WAS TAKEN TO THE HOSP BUT FURTHER INFO REGARDING THE EVENT WAS NOT PROVIDED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60528 | CONTOUR | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | 7080G | 2GC3C01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |