FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK AVIVA
MDR report key: 1222409
·
Received November 5, 2008
Report
- Report Number
- 1823260-2008-08166
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- October 22, 2008
- Report Date
- November 5, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K043474
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED SHE OBTAINED AN ERROR FOR THE LAST 4 DAYS ON HER AVIVA SYSTEM AND SHE BEGAN FEELING HYPOGLYCEMIC SYMPTOMS. REPORTER STATED SHE TREATED HERSELF WITH A GLUCAGON SHOT BUT THAT SHE STILL PASSED OUT SHORTLY LATER. REPORTER STATED THAT THE PARAMEDICS WERE CALLED, THEY TOOK HER TO THE HOSPITAL, AND SHE WAS GIVEN AN IV OF SALINE. REPORTER STATED SHE WAS DISCHARGED SEVERAL HOURS LATER, A RESULT OF 181 MG/DL WAS OBTAINED ON THE HOSPITAL SYSTEM, SHE WAS GIVEN 8 UNITS OF HUMALOG AND WAS PUT ON BED REST FOR THE NEXT 3 DAYS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK AVIVA | BLOOD GLUCOSE MONITORING DEVICE-NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention | CYMBALTA| LISINOPRIL| SINGULAIR| REQUIP| JANUMET| "PROMAZITHYNE"| LIPITOR| LYRICA| HUMALOG| ASPIRIN| LEVAQUIN| TYLENOL| PREDNISONE| AZAR |