FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SENSOR COMFORT TEST STRIPS
MDR report key: 746861
·
Received August 10, 2006
Report
- Report Number
- 1823260-2006-04062
- Event Type
- Injury
- Date Received
- August 10, 2006
- Date of Event
- April 21, 2005
- Report Date
- April 21, 2005
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ORIGINALLY RECEIVED ON APRIL 21, 2005: ROCHE DIAGNOSTICS BELGIUM SCHAARBEKLEI 198 1800 VILVOORDE, BELGIUM
Description of Event or Problem · 1
A PATIENT TREATED WITH OCTAGAM (AN INTRAVENOUS IMMUNE GLOBULIN, CONTAINING MALTOSE, WHICH IS A LABELED INTERFERENT FOR THE TEST STRIPS) WAS REPORTEDLY EXHIBITING SYMPTOMS OF HYPOGLYCEMIA. REPORTER STATED THAT PATIENT'S BLOOD GLUCOSE WAS TESTED, USING THE SUSPECT DEVICE, WITH A RESULT OF 104 MG/DL. PATIENT'S BLOOD GLUCOSE WAS RETESTED, USING A DIFFERENT MANUFACTURER'S DEVICE, WITH A RESULT OF < 20 MG/DL. REPORTER DID NOT PROVIDE ANY INFORMATION PERTAINING TO PATIENT'S TREATMENT OR CURRENT CONDITION. NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SENSOR COMFORT TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIAGNOSTICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | ACCU-CHEK INFORM| OCTAGAM, THERAPY DATES |