ONE TOUCH ULTRA METER
Report
- Report Number
- 2939301-2008-02352
- Event Type
- Injury
- Date Received
- October 15, 2008
- Report Date
- September 10, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
TEST STRIP LOT # NOT PROVIDED.
IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD AN "ERROR 2" ISSUE. IT IS NOT KNOWN WHEN THE ALLEGED METER ISSUE BEGAN. THE PT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. HOWEVER, ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE BEGAN, THE PT CLAIMED THAT SHE DEVELOPE SYMPTOM OF BLURRY VISION AND LIGHTHEADEDNESS. THE PT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER AND WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: WHEN THE ALLEGED METER ISSUE BEGAN, WHAT DATE/TIME THE SYMPTOMS STARTED, HER TESTING FREQUENCY, HER MEDICATION AND DIABETES MGMT REGIMENS, AND WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. THE PT WAS REPORTEDLY USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE REPORTED METER ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Life Threatening |