FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2152126
·
Received July 7, 2011
Report
- Report Number
- 1823260-2011-03641
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 15, 2011
- Report Date
- September 20, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CUSTOMER STATES HE TESTED 31.5 MMOL/L AND 8.9 MMOL/L WITHIN 10 MINUTES ON THE AVIVA SYSTEM AND ADMINISTERED HUMALOG BASED ON THE RESULT OF 31.5 MMOL/L. 10 MINUTES LATER CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS. HE WAS TAKEN TO THE HOSPITAL AND TREATED WITH AN UNSPECIFIED INJECTION. LOW BLOOD GLUCOSE SYMPTOMS IMPROVED AND CUSTOMER WAS RELEASED FROM THE HOSPITAL 4 HOURS LATER. REQUESTED RETURN OF SUSPECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 064 YR | Required Intervention | CODEINE| HUMALOG| ASPIRIN| UNK SLOW-ACTING INSULIN AT NIGHT |