FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SMARTVIEW TEST STRIPS
MDR report key: 3063402
·
Received April 17, 2013
Report
- Report Number
- 1823260-2013-02339
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 24, 2013
- Report Date
- April 22, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K113137
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) - COMPACT PLUS SYSTEM (B)(6) - NANO SYSTEM.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE TWO SYSTEMS WITHIN 10 MINUTES: 471 MG/DL, 183 MG/DL (COMPACT PLUS) AND 132 MG/DL (NANO). 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 |
|---|---|---|---|---|---|---|---|
| 164555 | ACCU-CHEK ® SMARTVIEW TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 028 YR | NPH NOVOLIN| HUMAN NOVOLIN| PRENATAL VITAMINS |