OT ULTRALINK METER
Report
- Report Number
- 2939301-2010-10937
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Report Date
- December 8, 2010
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K) # IS K073231.
FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 01/19/2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.
ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY LOW COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT TESTS HER BLOOD GLUCOSE 4-7 TIMES A DAY AND MANAGES HER DIABETES WITH HUMALOG INSULIN (SLIDING SCALE). THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010. THE PATIENT STATED SHE CONTINUED TO TAKE HER USUAL DOSE OF HUMALOG INSULIN (ABOUT 35 UNITS). THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "131 MG/DL" WITH THE SUBJECT METER AND "416 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HER HUSBAND FOUND HER "PASSED OUT" ON THE FLOOR. THE PATIENT'S HUSBAND WORKED WITH HER FOR ABOUT 30 MINUTES BEFORE SHE STARTED TO REGAIN CONSCIOUSNESS. THE PATIENT STATED SHE WAS GIVEN ORANGE JUICE AS TREATMENT. ON THE EVENING OF (B)(6) 2010, THE PATIENT STATED SHE OBTAINED A BLOOD GLUCOSE RESULT OF "75 MG/DL" WITH THE SUBJECT METER. AT THAT TIME, THE PATIENT ATE 2 PETITE CAKES AND DRANK ORANGE JUICE TO RELIEVE HER "LOW SYMPTOMS." THAT SAME DAY, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "134, 168, 151, 155 AND 75 MG/DL" WITH THE REPORTED DEVICE. BY LUNCHTIME, ON THE DAY OF THE ALLEGED ISSUE, THE PATIENT FELT A SYMPTOM OF "FREQUENT URINATION." THE PATIENT CONFIRMED SHE NO LONGER TESTED ON THE SUBJECT METER DUE TO THE LARGE DISCREPANCY OF THE RESULTS THAT MORNING. THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "434, 284, 348 AND 248 MG/DL" ON THE OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S INITIAL SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. IN ADDITION, THE PATIENT CONFIRMED SHE DID NOT ATTEMPT TO CONTINUE TESTING WITH THE REPORTED DEVICE AFTER THE ALLEGED ISSUE; THEREFORE, THE LFS BLOOD GLUCOSE METER WAS NOT THE CAUSE OF THE REPORTED SYMPTOMS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT ULTRALINK METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 2925375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |