FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT PLUS
MDR report key: 1616675
·
Received February 26, 2010
Report
- Report Number
- 1823260-2010-01280
- Event Type
- Malfunction
- Date Received
- February 26, 2010
- Date of Event
- December 29, 2009
- Report Date
- March 11, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- 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). THE DEVICE WAS FOUND TO MEET SPEC.
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B) (6). - (B) (4)
Description of Event or Problem · 1
CALLER REPORTEDLY RECEIVED RESULT OF 0.3 MMOL/L ON THE COMPACT PLUS SYSTEM. THE RESULT IS OUTSIDE THE NUMERIC RANGE OF 0.6-33.3 MMOL/L OF THE DEVICE. MANUFACTURER'S LOCAL LAB ALSO REPORTED A VALUE OF 34.1 MMOL/L. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.
Description of Event or Problem · 1
CALLER REPORTEDLY RECEIVED RESULT OF 0.3 MMOL/L ON THE COMPACT PLUS SYSTEM. THE RESULT IS OUTSIDE THE NUMERIC RANGE OF 0.6-33.3 MMOL/L OF THE DEVICE. MANUFACTURER'S LOCAL LAB ALSO REPORTED A VALUE OF 34.1 MMOL/L. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® COMPACT PLUS | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |