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

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Seizures (2063)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa alleging that their onetouch ultra meter was reading inaccurately erratic as well as providing an inaccurate result compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient stated that the alleged inaccuracy issue occurred between 10:30 and 11am on (b)(6) 2018.At this time the patient obtained blood glucose results of ¿26 and 83mg/dl¿ with the subject meter within 20 minutes of one another.The patient also compared the result of ¿86mg/dl¿ to a result of ¿29mg/dl¿ obtained on another device within 30 minutes of one another.Based on statistical methodology, the calculated difference of the alleged erratic blood glucose results exceeds lfs¿ criteria for precision.The patient did not state what medication, if any, they take to manage their diabetes and did not state whether they had taken any action with regards to their normal diabetes management regimen as a result of the alleged product issue.The patient stated that 10-15 minutes later they had a ¿seizure¿.As a result of this the patient was treated by the emergency medical services (ems) with glucose at 11am on (b)(6) 2018.The ems also measured the patient¿s blood glucose with their own meter and obtained a blood glucose result of ¿29mg/dl¿.At the time of troubleshooting the cca noted that unit of measure was set correctly on the subject meter.The patient did not have control solution available to walk through a control solution test with the cca.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after obtaining allegedly inaccurate results with the subject meter.

• Brand Name: OT ULTRA 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: 7649446
• MDR Text Key: 112705463
• Report Number: 3008382007-2018-01837
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062195
• 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: 06/21/2018

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
• Other Device ID Number: 1-AV-1086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2018
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 38 YR
• Patient Weight: 54