FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2900430
·
Received January 7, 2013
Report
- Report Number
- 1823260-2013-00137
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- November 27, 2012
- 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
- OH, 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
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 249 MG/DL AND 79 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 |
|---|---|---|---|---|---|---|---|
| 7057 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | AMLODIPINE| ASPIRIN| CARVEDILOL 2X DAILY| CILOSTAZOL 2X DAILY| HUMALOG IU 100| ISOSORB MONO 1X DAILY| LIPITOR 1X DAILY| LISINOPRIL 1X DAILY| MEDTRONICS MINIMED INSULIN PUMP| NITROSPRAY| PLAVIX 1X DAILY| ZETIA 1X DAILY| CARVEDILOL 2X DAILY| PLAVIX 1X DAILY| AMLODIPINE| ISOSORB MONO 1X DAILY| ASPIRIN| ZETIA 1X DAILY| NITROSPRAY| MEDTRONICS MINIMED INSULIN PUMP| LIPITOR 1X DAILY| LISINOPRIL 1X DAILY| CILOSTAZOL 2X DAILY| HUMALOG IU 100 |