FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® ADVANTAGE
MDR report key: 2070696
·
Received April 27, 2011
Report
- Report Number
- 1823260-2011-02278
- Event Type
- Injury
- Date Received
- April 27, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 27, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K032552
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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
CUSTOMER'S HUSBAND STATES THAT THE CUSTOMER WAS DISORIENTED AND NEEDED TO TEST HER BLOOD SUGAR, BUT THE CUSTOMER WAS OBTAINING AN ERROR WHEN INSERTING THE STRIP. CUSTOMER HAD PRE-DOSED THE STRIP. CUSTOMER'S HUSBAND THEN STATED THAT THE CUSTOMER WAS NOW UNCONSCIOUS AND CONTACTED EMERGENCY SERVICES. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® ADVANTAGE | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |