FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3230365
·
Received July 16, 2013
Report
- Report Number
- 1823260-2013-04299
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 23, 2013
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PATIENT
- 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 RESULTS OF 224 MG/DL, 110 MG/DL, AND 119 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 |
|---|---|---|---|---|---|---|---|
| 329833 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | ASPIRIN 1XDAY| HCT HYDROCHLOROTHIAZIDE| LISINOPRIL| MULTIVITAMIN 1 X DAY| NOVOLIN N 2 X DAY| NOVOLIN R 3 X DAY| PREVACID| RANITIDINE| SIMVASTATIN| WALKER| PREVACID| LISINOPRIL| MULTIVITAMIN 1 X DAY| WALKER| NOVOLIN N 2 X DAY| ASPIRIN 1XDAY| NOVOLIN R 3 X DAY| HCT HYDROCHLOROTHIAZIDE| SIMVASTATIN| RANITIDINE |