ONE TOUCH ULTRAMINI METER
Report
- Report Number
- 2939301-2008-01044
- Event Type
- Injury
- Date Received
- June 10, 2008
- Report Date
- May 20, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.
IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO. THE PT TESTS HER BLOOD GLUCOSE AT LEAST FOUR TIMES A DAY. SHE ALSO MANAGES HER DIABETES VIA INSULIN: ONE UNIT FOR EVERY 15 CARBOHYDRATES AND ONE UNIT FOR EVERY 30 MG/DL THAT SHE GOES OVER. THE PT CLAIMED THAT SHE DECREASED THE DOSAGE TO ONE UNIT FOR EVERY 60 MG/DL AFTER THE REPORTED METER ISSUE. THE PT CLAIMED THAT THE SUBJECT METER WAS READING HIGH FOR ABOUT A MONTH BEFORE CONTACTING LFS. AS A RESULT OF THE "HIGH" READINGS OBTAINED ON THE SUBJECT METER, THE PT DECREASED HER BOLUS INSULIN TO HALF BASED ON HER FEELING "TOO LOW". DURING THE SECOND WEEK OF THE MONTH, ANOTHER ONETOUCH ULTRAMINI METER WAS PURCHASED TO PERFORM BACK-TO-BACK TESTING "TO BE SAFE". A REPORTED BLOOD GLUCOSE RESULTS OF "490 MG/DL" WITH A SUBJECT METER AND "544 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS MEETS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL FOR LFS ACCURACY CRITERIA. AS A RESULT OF OBTAINING HIGH READINGS ON BOTH METERS, THE PT DECIDED TO "SPLIT THE DIFFERENCE OF THE RESULTS AND DOSE HER BOLUS INSULIN ON THE AVERAGE OF THE RESULTS". ON AN UNSPECIFIED DATE IN THE SAME WEEK, THE PT CLAIMED OF "BOTTOMING-OUT" AND HER DAUGHTER CALLED FOR EMERGENCY MEDICAL SERVICES (EMS). WHILE IN THE INTERIM, HER DAUGHTER ADMINISTERED GLUCOSE GEL, GLUCOSE TABLET, AND GLUCAGON. WHEN THE EMS ARRIVED, A BLOOD GLUCOSE TEST WAS PERFORMED ON THE EMT METER WITH A RESULT OF "38 MG/DL". THE PT ATTRIBUTED THAT SHE WAS "MORE ACTIVE" DURING THE SAME WEEK. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: WHEN THE PT TYPICALLY TESTS HER BLOOD GLUCOSE DURING THE DAY, WHEN THE TWO READINGS WERE TAKEN, WAS SHE TESTED ON THE SUBJECT METER BEFORE THE EMS ARRIVED AND AFTER THE INCIDENT, WHEN THE PT BOTTOMED-OUT THAT WEEK, AND WHAT WERE HER SYMPTOMS? IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT TYPE OF TREATMENT WAS GIVEN (IF ANY) BY THE EMS AND WHY DID THE PT DECREASED HER INSULIN WHEN SHE WAS GETTING "HIGH" READINGS. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE RESULT IN THE MEMORY MATCHED. THE UNIT OF MEASUREMENT WAS SET CORRECTLY TO "MG/DL". THE PT CLEANED THE PUNCTURE AREA CORRECTLY; HOWEVER, THE TESTING TECHNIQUE WHEN REVIEWED WAS INCORRECT (USE ERROR). THE PATIENT'S PRODUCTS ARE BEING REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE WAS GETTING INACCURATE "HIGH" READINGS ON THE SUBJECT METER COMPARED TO A "38 MG/DL" ON AN EMS METER. SHE REPORTED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND WAS TREATED WITH ORAL GLUCOSE AFTER THE REPORTED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRAMINI METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | 2781546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Life Threatening| R |