FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2890835
·
Received December 31, 2012
Report
- Report Number
- 1823260-2012-06603
- Event Type
- Malfunction
- Date Received
- December 31, 2012
- Date of Event
- December 2, 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
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. (B)(4).
Description of Event or Problem · 1
CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS WITH TWO DIFFERENT METERS: AVIVA SYSTEM 1: 88 MG/DL AT 1100, 77 MG/DL AT 1118, 204 MG/DL AT 1120, 97 MG/DL AT 1122. AVIVA SYSTEM 2: 93 MG/DL AT 1059, 547 MG/DL AT 1103, 56 MG/DL AT 1116. READINGS WERE ALL TAKEN ON THE SAME DAY. 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 | 490980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 073 YR | NOVOLOG| LANTUS |