FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 4200539
·
Received October 24, 2014
Report
- Report Number
- 1823260-2014-08261
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- September 28, 2014
- 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
- MT, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 67 MG/DL, 80 MG/DL, AND 139 MG/DL. NO DEATH OR SERIOUS INJURY REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678861 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 493695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | ASPIRIN| ATORVASTATIN| CARVEDILOL| COUMADIN| FUROSEMIDE| HEARING AID| LANTUS| LEVOTHYROXINE| LOSARTAN| PLAVIX| POTASSIUM| ROPINIROLE| WALKER| PLAVIX| POTASSIUM| WALKER| CARVEDILOL| LANTUS| ROPINIROLE| ASPIRIN| LOSARTAN| HEARING AID| COUMADIN| FUROSEMIDE| ATORVASTATIN| LEVOTHYROXINE |