FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA EXPERT
MDR report key: 3970228
·
Received July 31, 2014
Report
- Report Number
- 1823260-2014-05733
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- May 1, 2014
- Report Date
- August 1, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CUSTOMER REPORTED THE ACTIVE INSULIN AMOUNT, WHICH IS USED IN BOLUS CALCULATIONS ON THE BLOOD GLUCOSE MONITOR, IS INCORRECT. INSULIN HAS BEEN LISTED AS ACTIVE AS MUCH AS 12 HOURS LATER. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION. NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448414 | ACCU-CHEK ® AVIVA EXPERT | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | EUTIROX| EUTIROX |