FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA CONTOUR
MDR report key: 1163646
·
Received September 9, 2008
Report
- Report Number
- 1826988-2008-00994
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 15, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE ADVOCATE STATED THAT THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 453 MG/DL USING HIS CONTOUR METER. SOMETIME LATER, PARAMEDICS WERE CALLED AND THEY TESTED THE CUSTOMER'S GLUCOSE AT 30 MG/DL USING THEIR METER. THE ADVOCATE DID NOT MENTION TREATMENT, BUT MOST LIKELY THE CUSTOMER WAS TREATED WITH GLUCOSE. NO OTHER INFORMATION WAS PROVIDED REGARDING THE EVENT. WHEN CUSTOMER SERVICE GATHERED REAGENT INFORMATION, IT WAS DISCOVERED THE CUSTOMER HAD BEEN USING EXPIRED TEST STRIPS. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA CONTOUR | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 7151A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |