FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3061635
·
Received April 16, 2013
Report
- Report Number
- 1823260-2013-02316
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- March 20, 2013
- Report Date
- July 28, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULT OF 192 MG/DL, TOOK 10 UNITS OF HUMALOG, AND SAME SYSTEM RETEST RESULT WITHIN 10 MINUTES WAS 46 MG/DL. 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 |
|---|---|---|---|---|---|---|---|
| 162882 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | AMIODARONE 1XDAY| ASPIRIN 1XDAY| ATORVASTATIN 1XDAY| COMBIGAN| CPAP| FERMASIAN 1XDAY| HUMALOG 3XDAY| LANTUS 1XDAY| LUMIGAN| METOPROLOL 1XDAY| NEBULULIZER| OXYGEN| PACEMAKER| TAMSULOSIN 1XDAY| TRILIPIX 1XDAY| VITAMIN D 1XDAY| ASPIRIN 1XDAY| ATORVASTATIN 1XDAY| TAMSULOSIN 1XDAY| LUMIGAN| PACEMAKER| CPAP| NEBULULIZER| OXYGEN| COMBIGAN| METOPROLOL 1XDAY| HUMALOG 3XDAY| FERMASIAN 1XDAY| LANTUS 1XDAY| AMIODARONE 1XDAY| VITAMIN D 1XDAY| TRILIPIX 1XDAY |