FDA Adverse Event
Injury
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1130467
·
Received August 20, 2008
Report
- Report Number
- 1826988-2008-00898
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE ADVOCATE STATED THAT THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED READINGS OF 318 AND 420 MG/DL USING HIS CONTOUR METER. HE TOOK INSULIN BASED ON THE READINGS AND SOMETIME LATER, HIS BLOOD GLUCOSE DROPPED TO 42 MG/DL. THE CUSTOMER FELT DIZZY WHEN HIS BLOOD GLUCOSE DROPPED, BUT HE DID NOT REQUIRE ANY TYPE OF TREATMENT. TROUBLESHOOTING SHOWED THE CONTOUR SYSTEM TO BE OPERATING AS DESIGNED, BUT THE TEST STRIPS AND METER WERE STILL RETURNED FOR EVAL. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR TEST STRIPS (50) | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | 7098B | 7LC3D16 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |