OT ULTRALINK METER

Report

Report Number: 2939301-2010-07480
Event Type: Malfunction
Date Received: September 1, 2010
Date of Event: August 24, 2010
Report Date: August 25, 2010
Manufacturer: LIFESCAN, INC.
Product Code: MDS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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.

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

(B) (6) PATIENT WITH COMPLEX MEDICAL HISTORY WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF A LEAKING BROVIAC CATHETER AND PLACEMENT OF CENTRAL LINE. THE OLD INCISION WAS REOPENED AND THE CATHETER WAS LOCATED WITHOUT DIFFICULTY. THE CATHETER WAS TRANSECTED AND THE EXTERNAL PORTION OF THE CATHETER WAS DISSECTED FREE FROM THE EXIT SITE. A GUIDE WIRE WAS USED TO PASS DOWN THE CATHETER IN AN ATTEMPT TO DILATE THE EXTERNAL JUGULAR VEIN AND INSERT A LARGER CATHETER. DURING THIS PROCESS, THE DISTAL SEGMENT OF THE CATHETER SLIPPED ALONG THE WIRE AND THE FRAGMENT COULD NOT BE LOCATED. FLUOROSCOPY WAS UTILIZED AND IT WAS NOTED THAT FRAGMENT HAD PROGRESSED INTRAVASCULARLY. AS THE SURGEON ATTEMPTED TO PULL BACK ON THE WIRE, THE TUBING SLIPPED FURTHER AND MIGRATED TO THE RIGHT ATRIUM. THE GUIDE WIRE WAS REMOVED AND THE PATIENT WAS TAKEN TO THE CARDIAC CATH LAB WHERE THE FRAGMENT WAS REMOVED VIA A FEMORAL VEIN CATHETERIZATION. THE PATIENT WAS TRANSFERRED TO THE RECOVER ROOM IN SATISFACTORY AND STABLE CONDITION. NO FURTHER COMPLICATIONS WERE NOTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

Description of Event or Problem · 1

THE LAY USER / PATIENT CONTACTED LFS ON (B)(6), 2010 ALLEGING INACCURATE HIGH READING AND ERRATIC READINGS ON HER ONE TOUCH ULTRALINK METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION: THE PATIENT MENTIONED THAT PRIOR TO TESTING ON (B)(6), 2010 AT 1:56 AM SHE WAS EXHIBITING LOW SYMPTOMS, "WEIRD DREAMS" AND WAS FEELING A BIT SHAKY DURING HER SLEEP. SHE THEN TESTED HER BLOOD GLUCOSE ON HER ULTRALINK METER AND OBTAINED A 1:56 AM 264MG/DL, 1:57 AM 297MG/DL , 1:58 AM 235 MG/DL, 1:59AM 489 MG/DL , 2:02 AM 271MG/DL AND 2:03 AM 443MG/DL. LESS THAN 30 MINUTES LATER, THE PATIENT TESTED ON A ULTRAMINI METER AND OBTAINED A 75 MG/DL AT 2:20AM. THE PATIENT THEN SELF-TREATED WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN AND READINGS PRIOR TO THE SYMPTOMS. THE PRODUCTS WERE REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT EXHIBITED SYMPTOMS PRIOR TO TESTING. THE PATIENT SYMPTOMS CORRELATED WITH THE SELF-TREATMENT AND THE PATIENT DENIED SEEKING ANY FURTHER MEDICAL ATTENTION. THE COMPLAINT IS BEING REPORTED SINCE THE BACK TO BACK READINGS ARE GREATER THAN 20 MG/DL (1.11 MMOL/L) OR 20% AND THE METER TO OTHER METER COMPARISON EXCEEDS THE EXPECTED VALUE OF <=30% AND /OR <=30 MG/DL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	MDS	LIFESCAN, INC.		3023837

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR