MULTISTIX 10SG
Received Jun 21, 2001 · Event occurred Apr 16, 2001
Report 1810909-2001-00035 · MDR key 339696
Device
Generic name
Ivd - Urinalysis-multiple Visual/glucose Parameters
Manufacturer
Bayer DiagnosticsModel number
*Catalog number
2300A
Lot number
0L06C
Product problems
- False Negative Result
- Use of Device Problem
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
- Blood glucose, high
Narrative
Description of Event or Problem
A PHYSICIAN FROM UK COMPLAINED THAT THE URINE GLUCOSE READINGS WERE READING FALSE NEGATIVE USING BAYER VISUAL REAGENT STRIPS PRODUCT, MULTISTIX 10SG. PHYSICIAN CLAIMS THAT THE PATIENT IS NOW IN SERIOUS RISK OF FALLING INTO A DIABETIC COMA. THE URINE AND BLOOD TESTS HAVE BEEN SENT TO THE LABORATORY AND CONFIRMED THAT THE PATIENT'S GLUCOSE LEVELS IN BLOOD SAMPLE IS ABNORMALLY HIGH. IN HOUSE INVESTIGATION OF AFFECTED PRODUCT DID NOT CONFIRM THE ALLEGED COMPLAINT. THE PRODUCT CLAIMS CLEARLY INDICATE THAT THE PRODUCT IS INTENDED AS A SCREEN TEST TO IDENTIFY POTENTIAL DIABETICS WHO'S BLOOD GLUCOSE LEVELS ARE HIGH ENOUGH TO CAUSE TO SPILL GLUCOSE OVER THAT INDIVIDUAL'S THRESHOLD INTO THE URINE. THE PRODUCT IS NOT INTENDED TO MONITOR OR REGULATE A DIABETIC'S BLOOD GLUCOSE LEVEL. IT SEEMS TO BE APPROACH TAKEN BY THE PHYSICIAN WHO REPORTED THIS COMPLAINT.