FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 2855106
·
Received December 3, 2012
Report
- Report Number
- 1823260-2012-06086
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- October 24, 2012
- Report Date
- December 7, 2012
- 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). ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED. STRIPS NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 1
CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS OF BETWEEN 16 AND 17 MMOL/L AND 3.8 MMOL/L WITHIN 10 MINUTES. THE CALLER WAS ABLE TO SELF-TREAT SYMPTOMS OF DIZZINESS. NO ADVERSE EVENT WAS REPORTED. STRIPS NOT AVAILABLE FOR RETURN REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 033 YR | MYLAN-GLICLAZIDE 1XDAY| METFORMIN 2X/DAY| ASPIRIN 1X A DAY |