FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 6357239
·
Received February 24, 2017
Report
- Report Number
- 3011393376-2017-01144
- Event Type
- Malfunction
- Date Received
- February 24, 2017
- Date of Event
- February 9, 2017
- Report Date
- May 3, 2017
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- NBW
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER GOT THE FOLLOWING READINGS WITHIN 10 MINUTES: 489 MG/DL READING AT 4:00PM (B)(6) 2017; 28 MG/DL READING AT 4:10PM (B)(6) 2017. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139443 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | 496453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |