FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® MULTICLIX
MDR report key: 2111650
·
Received June 2, 2011
Report
- Report Number
- 1823260-2011-02949
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- May 23, 2011
- Report Date
- June 2, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 STATES CUSTOMER WAS UNABLE TO USE HER MULTICLIX DEVICE WHILE HAVING LOW BLOOD GLUCOSE SYMPTOMS BECAUSE SHE DID NOT KNOW HOW TO USE THE DEVICE. EMERGENCY MEDICAL TECHNICIANS (EMTS) WERE CALLED; CUSTOMER TESTED 32 MG/DL ON THE PROFESSIONAL DEVICE AND WAS TREATED WITH A GLUCOSE IV. LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® MULTICLIX | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 074 YR | Required Intervention | TRUETRACK BLOOD GLUCOSE METER| GLUCOPHAGE |