FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK MOBILE TEST STRIPS
MDR report key: 2031817
·
Received March 28, 2011
Report
- Report Number
- 1823260-2011-01650
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 22, 2011
- Report Date
- April 27, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- 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 15 MMOL/L ON MOBILE SYSTEM,TOOK 4 UNITS OF HUMALOG, RETESTED AT 7.4 MMOL/L ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.
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 | 277072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 075 YR | HUMALOG| PERSANTINE RETARD| ALBYL-E |