OT ULTRAMINI METER
Report
- Report Number
- 2939301-2011-00764
- Event Type
- Injury
- Date Received
- January 24, 2011
- Report Date
- January 14, 2011
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
THE 510(K) # IS K061118.
ON (B)(6), 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HER EXPECTED RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ABOUT 2 MONTHS AGO PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF '182, 160, 190, 179 AND 213 MG/DL' WITH THE SUBJECT METER. THE CUSTOMER CARE ADVOCATE (CCA) WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH AMARYL PILLS (AMOUNT NOT SPECIFIED). THE PATIENT STATED SHE INCREASED HER USUAL DOSE OF AMARYL (4 MG). AT AN UNSPECIFIED TIME, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF NAUSEATED, SHAKY, SWEATY AND WEAK. THE PATIENT DID NOT SPECIFY ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE UNIT OF MEASUREMENT WAS SET CORRECTLY. THE CCA WALKED THE PATIENT THROUGH CORRECTLY CODING THE METER TO MATCH THE TEST STRIP. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT ULTRAMINI METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3068171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Life Threatening |