MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4339487

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Syncope (1610); Sweating (2444); Shaking/Tremors (2515)

Event Date 06/14/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the patient contacted lifescan (lfs) alleging that her onetouch ultra 2 meter was reading inaccurately high compared to feelings/normal results.The complaint was classified based on the customer care advocate (cca) documentation.The patient stated that the issue first occurred on (b)(6) 2018.The patient detailed that she tested her blood and obtained an alleged inaccurately high glucose result of 300 mg/dl on the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine the possibility of inaccuracy.The patient stated that she manages her diabetes with insulin (self-adjuster) and reported that she took an increased dose of medication in response to the alleged product issue.The patient reported that within an hour after the alleged product issue began she developed symptoms of ¿shaky, clamminess and feeling of passing out¿.She stated that she self-treated with food and drink ¿drank coca cola¿.The patient denied that she obtained a blood glucose result on another device.At the time of trouble shooting, the cca confirmed that the meter was set with the correct unit of measure at the time of testing.The test strips were stored correctly and within expiry date.The patient did not have control solution to perform a control solution test.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed symptoms that meet lfs¿ criteria for a serious injury adverse event after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT ULTRA2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7662052
• MDR Text Key: 113159180
• Report Number: 3008382007-2018-01882
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4339487
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2018
• Device Age: 79 MO
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 68