FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3120586
·
Received May 20, 2013
Report
- Report Number
- 1823260-2013-03063
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Date of Event
- April 4, 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
- FL, 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 "IN THE 400S" MG/DL, PROFESSIONAL SYSTEM RESULT OF 120 MG/DL WITHIN 10 MINUTES. 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 |
|---|---|---|---|---|---|---|---|
| 222822 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Male | ASPIRIN| CALCIUM| CARBIDOPA 50/LEVODOPA| CLOPIDOGREL| DONEPEZIL| GLYBURIDE| ISOSORBIDE MONONITRATE| LAMOTRIGINE| LISINOPRIL| OXYBUTYNIN| SIMVASTATIN| TRAZODONE HCL| VITAMIN D| WALKER| WHEELCHAIR| TRAZODONE HCL| DONEPEZIL| LISINOPRIL| WALKER| GLYBURIDE| SIMVASTATIN| ASPIRIN| VITAMIN D| CARBIDOPA 50/LEVODOPA| ISOSORBIDE MONONITRATE| CLOPIDOGREL| WHEELCHAIR| OXYBUTYNIN| CALCIUM| LAMOTRIGINE |