FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM II TEST STRIPS
MDR report key: 3832754
·
Received May 27, 2014
Report
- Report Number
- 1823260-2014-03711
- Event Type
- Malfunction
- Date Received
- May 27, 2014
- Date of Event
- April 28, 2014
- Report Date
- June 24, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER STATES THE PATIENT TESTED HI (GREATER THAN 600 MG/DL) ON THE INFORM II SYSTEM WHILE A COMPARISON LAB RETURNED AS 173 MG/DL WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311043 | ACCU-CHEK ® INFORM II TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 471652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 060 YR |