FDA Adverse Event
Injury
Summary report: N
CONTOUR NEXT
MDR report key: 4122595
·
Received September 26, 2014
Report
- Report Number
- 1826988-2014-00326
- Event Type
- Injury
- Date Received
- September 26, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- PMA / PMN Number
- K110894
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION, IS NOT PROVIDED DUE TO PRIVACY LAWS.
Description of Event or Problem · 1
AN ADVOCATE FROM (B)(6) STATED HIS WIFE HAD HYPOGLYCEMIC SYMPTOMS BUT THE CONTOUR NEXT LINK GAVE HER A BLOOD GLUCOSE READING OF 127MG/DL. HE CALLED AN AMBULANCE AND THE PATIENT WAS RETESTED ON A DIFFERENT METER WITH A READING OF 20MG/DL. THE PARAMEDIC GAVE HER FOUR GLUCOSE UNITS. THE PATIENT WAS TAKEN TO THE HOSPITAL AND A BLOOD TEST WAS PERFORMED ON HER. THE READING WAS 64MG/DL. INFORMATION REGARDING FURTHER TREATMENT WAS NOT PROVIDED. SHE WAS ULTIMATELY DISCHARGED AND SENT HOME. NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601009 | CONTOUR NEXT | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE LLC | 4AFED03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |