FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® ACTIVE
MDR report key: 2193535
·
Received August 5, 2011
Report
- Report Number
- 1823260-2011-04221
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 16, 2011
- Report Date
- August 5, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K021827
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTS BEING UNABLE TO OBTAIN A RESULT DUE TO AN ERROR ON THE ACTIVE S SYSTEM WHILE CUSTOMER WAS PASSED OUT. CALLER TREATED THE CUSTOMER WITH A GLASS OF ORANGE JUICE AND A PIECE OF CHOCOLATE. CUSTOMER REGAINED CONSCIOUSNESS WITHIN A FEW MINUTES. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® ACTIVE | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 061 YR | Required Intervention | OXYCODONE| METFORMIN |