FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT PLUS (GT)
MDR report key: 2110392
·
Received June 1, 2011
Report
- Report Number
- 1823260-2011-02912
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- March 16, 2011
- Report Date
- June 3, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
UPON REVIEW BY THE FIRST LEVEL INVESTIGATION UNIT (FLIU), IT WAS FOUND THAT THE COMPACT PLUS METER SHOWED EVIDENCE OF MELTING. ON THE BACK SIDE OF THE METER, NEAR THE BOTTOM LEFT CORNER OF THE BATTERY DOOR, A HOLE APPEARD TO HAVE MELTED THROUGH THE METER HOUSING. THIS ISSUE WAS FOUND DURING REVIEW; ELECTRIC SHORTING DID NOT OCCUR DURING FLIU TESTING. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® COMPACT PLUS (GT) | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |