FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2499106
·
Received March 21, 2012
Report
- Report Number
- 1823260-2012-01527
- Event Type
- Malfunction
- Date Received
- March 21, 2012
- Date of Event
- March 10, 2012
- Report Date
- April 24, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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 REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 199 MG/DL, 241 MG/DL, AND HI (GREATER THAN 600 MG/DL). 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 TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 048 YR | JANUVIA| METFORMIN |