FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® AVIVA
MDR report key: 3133697
·
Received May 29, 2013
Report
- Report Number
- 1823260-2013-03210
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- April 30, 2012
- Report Date
- July 19, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER DROPPED THE AVIVA METER AND IT CRACKED INTO PIECES. CUSTOMER PICKED UP THE METER AND CUT HER FINGER. HER BOYFRIEND TOOK HER TO THE HOSPITAL AND "BEGGED THE HOSPITAL TO GIVE HER STITCHES BECAUSE IT LOOKED SO BAD." SHE RECEIVED STITCHES. CUSTOMER WAS NOT ADMITTED TO THE HOSPITAL. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236419 | ACCU-CHEK ® AVIVA | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 050 YR | Hospitalization| R | METFORMIN| HYDROCHLOROTHIAZIDE| FERROUS SULFATE| ATENOLOL| MELOXICAM| ATORVASTATIN| ASPIRIN| LISINOPRIL| AMLODIPINE| GLYBURIDE |