FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 4171661
·
Received October 14, 2014
Report
- Report Number
- 1823260-2014-07894
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 6, 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
- MA, 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 RESULTS OF 398 MG/DL AND 61 MG/DL WITHIN 1 MINUTE ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650078 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 492003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | CALTRATE D| CENTRUM| CLONIDINE| CPAP MACHINE| DETROL LA| FISH OIL| HUMALOG| HUMULIN 70/30| LANTUS| LODIPINE| LOW DOSE ASPIRIN| VITAMIN D| ZETIA| FISH OIL| VITAMIN D| LODIPINE| HUMALOG| DETROL LA| CALTRATE D| HUMULIN 70/30| LOW DOSE ASPIRIN| ZETIA| CPAP MACHINE| CENTRUM| LANTUS| CLONIDINE |