FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK INFORM II TEST STRIPS
MDR report key: 3051429
·
Received April 10, 2013
Report
- Report Number
- 1823260-2013-02201
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- February 27, 2013
- Report Date
- May 23, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). THE CALLER DID NOT PROVIDE PRODUCT INFORMATION FOR THE UNKNOWN ACCU-CHEK SYSTEM.
Description of Event or Problem · 1
CALLER STATES PATIENT TESTED 23.9 MMOL/L AND 5.4 MMOL/L ON THE INFORM II SYSTEM, AND HE TESTED 9.3 MMOL/L ON AN UNKNOWN ACCU-CHEK SYSTEM 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 |
|---|---|---|---|---|---|---|---|
| 148445 | ACCU-CHEK INFORM II TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 471040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 065 YR | UNKNOWN INSULIN |