FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 2442939
·
Received February 8, 2012
Report
- Report Number
- 1823260-2012-00720
- Event Type
- Malfunction
- Date Received
- February 8, 2012
- Date of Event
- February 3, 2012
- Report Date
- March 15, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING HOSPITALIZATION AT A TIME WHEN THE MOBILE SYSTEM GAVE A BLOOD GLUCOSE RESULT 5.8 MMOL/L. AN AMBULANCE WAS CALLED. AN UNSPECIFIED TIME LATER, EMERGENCY DOCTOR HAD A RESULT OF 3.4 MMOL/L, TREATED THE CUSTOMER WITH UNSPECIFIED GLUCOSE. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 278088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 071 YR | NOVORAPID |