FDA Adverse Event
Injury
Summary report: N
CONTOUR TEST STRIPS
MDR report key: 2112341
·
Received May 27, 2011
Report
- Report Number
- 1826988-2011-00295
- Event Type
- Injury
- Date Received
- May 27, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 4, 2011
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- PMA / PMN Number
- K062058
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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
THE ADVOCATE CONTACTED CUSTOMER SERVICE ON BEHALF OF THE CUSTOMER FROM (B)(6). SHE ALLEGED THAT THE CUSTOMER RECEIVED ERRATIC READINGS OF 26 AND 8 MMOL/L USING HIS CONTOUR METER. SHE GAVE HIM INSULIN BASED ON THE HIGH READING AND HE BECAME HYPOGLYCEMIC. THE ADVOCATE TREATED THE CUSTOMER FOR LOW BLOOD GLUCOSE. THE ADVOCATE WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | NOT PROVIDED | 0HC3D04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |