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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN, INC. ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT

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LIFESCAN, INC. ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 2988279
Device Problems Use of Incorrect Control Settings (1126); Use of Device Problem (1670); High Test Results (2457)
Patient Problems Emotional Changes (1831); Hypoglycemia (1912); Blurred Vision (2137); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Alteration In Body Temperature (2682)
Event Type  Injury  
Event Description

In 2010, the lay-user/reporter contacted lifescan (lfs) alleging that a one touch ultra 2 meter read inaccurately high. The pt tests his blood glucose 3 times a day. In 2009, the pt started taking precose 5 minutes before breakfast based on a doctor's prescription. The reporter indicated that the pt was given the reported meter eight days earlier, by an endocrinologist. Ever since he started using the meter, the reporter claimed that the pt had "sudden drops" and stated his blood glucose levels would go really low. Due to the lows, the reporter started performed meter-to-other meter comparisons. She compared the lfs meter with a meter used by her daughter's friend. In every case, the reporter claimed that the lfs meter read 20-25 points higher. In one case when the pt had symptoms of blurred vision, confusion, being emotional, having tremors, and feeling hot and cold, the pt tested his blood glucose on the reported meter and got "103 mg/dl. " within minutes, the pt tested on his daughter's friend's meter and got "69 mg/dl. " based on statistical methodology, the calculated difference of these glucose results exceeds the expected value of <=30% and/or <=30 mg/dl. The pt administered self-treatment by eating food which helped to relieve his symptoms. In another case towards the end of december 2009, the pt got another meter reading that was "normal" but he had the same symptoms noted earlier as feeling low. Since the meter allegedly gave a normal reading, the reporter did not attempt to treat the pt and just took him to an emergency room (er). The er informed the pt that his blood glucose level was "45 mg/dl" and that he had to be hospitalized overnight for treatment of hypoglycemia. The reporter was not sure if it was the meter or the precose that contributed to the hypoglycemic events. In another case, the pt reportedly obtained a result of "131 mg/dl" on the lfs meter and "93 mg/dl" on two other meters performed within 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. While speaking to the customer service representative (csr), the reporter discovered that the reported lfs meter was not coded correctly. She did not know the meter had to be coded. The meter, test strips, and control solution were replaced. Based on the info provided, this complaint is being reported due to the following conclusion: the reporter claimed that the pt developed symptoms suggestive of severe hypoglycemia and was hospitalized after the alleged issue began.

 
Manufacturer Narrative

Lifescan (lfs) has requested return of the subject product(s) for eval. 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.

 
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Brand NameONE TOUCH ULTRA2 METER
Type of DeviceGLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN, INC.
1000 gibraltar dr.
milpitas CA 95035
Manufacturer Contact
kelly stone
1000 gibraltar dr.
milpitas, CA 95035
4089564746
MDR Report Key1580096
MDR Text Key1443450
Report Number2939301-2010-00250
Device Sequence Number1
Product Code NBW
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation LAY USER/PATIENT
Type of Report Initial
Report Date 01/04/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device LOT Number2988279
OTHER Device ID Number1-99SMXF
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Other
Date Manufacturer Received01/04/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/27/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/13/2010 Patient Sequence Number: 1
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