FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK COMPACT PLUS
MDR report key: 1161202
·
Received September 15, 2008
Report
- Report Number
- 1823260-2008-06899
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 15, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K031755
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED SHE COULDN'T TEST BECAUSE OF AN ERROR MESSAGE ON HER COMPACT PLUS DEVICE. REPORTER STATED THAT TWO HOURS AFTER HER LAST ATTEMPT TO TEST AND OBTAINING THE ERROR MESSAGE, HER VISITING NURSE CAME AND OBTAINED A RESULT OF 587 MG/DL ON HER DEVICE. REPORTER STATED 911 WAS CALLED, THE PARAMEDICS OBTAINED A HIGH READING, TREATED HER WITH AN INSULIN IV, AND TOOK HER TO THE HOSPITAL. REPORTER STATED THAT AT THE HOSPITAL, HER BLOOD GLUCOSE WAS AROUND 500 MG/DL AND THEY TREATED HER WITH AN INSULIN IV UNTIL SHE WAS RELEASED EARLY THE NEXT MORNING. 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 COMPACT PLUS | BLOOD GLUCOSE MONITORING DEVICE - NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| R | HUMALOG - 1 YEAR - SLIDING SCALE| LANTUS 1 YEAR |