FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3854065
·
Received June 6, 2014
Report
- Report Number
- 1823260-2014-04132
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- April 25, 2014
- 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
- AZ, 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.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. ALL STRIPS HAD BEEN CONSUMED BY THE CUSTOMER PRIOR TO CONTACTING MANUFACTURER. SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 92 MG/DL AND 205 MG/DL. NO ACTIONS OR INACTIONS TAKEN BASED ON READINGS. NO DEATH OR SERIOUS INJURY REPORTED. CUSTOMER USED LAST STRIP IN THE VIAL. REPLACEMENT WAS SENT; METER REQUESTED TO BE RETURNED, NO STRIPS TO BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330855 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | ACTOS| AVANDIA| BLOOD PRESSURE MONITOR| BYDUREON| CHROMIUM PICOLINATE| CLOTRIMAZOLE| GLYBURIDE| INVOKANA 300MG| LANTUS SOLOSTAR| LISINOPRIL| METFORMIN| CHROMIUM PICOLINATE| GLYBURIDE| METFORMIN| AVANDIA| INVOKANA 300MG| LISINOPRIL| LANTUS SOLOSTAR| ACTOS| BYDUREON| CLOTRIMAZOLE| BLOOD PRESSURE MONITOR |