FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK COMFORT CURVE
MDR report key: 546759
·
Received September 23, 2004
Report
- Report Number
- 1823260-2004-00986
- Event Type
- Injury
- Date Received
- September 23, 2004
- Date of Event
- September 13, 2004
- Report Date
- September 14, 2004
- Manufacturer
- ROCHE DIAGNOSTICS CORP.
- Product Code
- CGA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CUSTOMER TESTED AND RECEIVED BLOOD GLUCOSE RESULTS OF 151, 143, 59 AND 161 MG/DL. THE CUSTOMER WAS FEELING EXTREMELY LOW BUT TOOK THEIR PILLS BASED ON THE DEVICE RESULTS. THEY FELT THEY WERE LOW SO THEY HAD SOME PANCAKE SYRUP AND WENT TO THE HOSP. AT THE HOSP THEIR DEVICE READ 135MG/DL AND THE CUSTOMER DEVICE READ 155MG/DL. A LAB PERFORMED BUT THE RESULT IS UNK. CONTROLS WERE IN RANGE. 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 COMFORT CURVE | BLOOD GLUCOSE MONITORING DEVICE | CGA | ROCHE DIAGNOSTICS CORP. | NA | 546708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization |