FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 3062867
·
Received April 17, 2013
Report
- Report Number
- 1823260-2013-02329
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 11, 2013
- Report Date
- April 17, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM (LOT NUMBER AND EXPIRATION DATE UNKNOWN). (B)(4).
Description of Event or Problem · 1
CUSTOMER RECEIVED RESULT OF 426 MG/DL ON THE MOBILE SYSTEM AND A RESULT OF 205 MG/DL ON THE COMPACT PLUS 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 |
|---|---|---|---|---|---|---|---|
| 165459 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 060 YR | HUMALOG 3 TIMES DAILY| LANTUS |