FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2880018
·
Received December 19, 2012
Report
- Report Number
- 1823260-2012-06440
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Date of Event
- November 27, 2012
- Report Date
- January 7, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA SYSTEM. (B)(6).
Description of Event or Problem · 1
CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 298 MG/DL (NANO) AND 138 MG/DL (AVIVA). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 075 YR | LISINOPRIL - 1X A DAY| METFORMIN| VERAPAMIL - 1X A DAY| LOVASTATIN - 1X A DAY| PANTOPRAZOLE - 1X A DAY |