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

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Shaking/Tremors (2515)

Event Date 06/21/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a reporter for the lay user/patient contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch verio iq meter read inaccurately erratic.The complaint was classified based on the customer service representative (csr) documentation.The reporter stated that the alleged meter inaccuracy began 10 days prior to contacting lfs.The reporter claimed the patient obtained blood glucose readings of ¿360, 73 and 83 mg/dl¿ with the subject meter, performed within an unspecified time of each other.Lifescan cannot confirm any inaccuracy from the data provided as the time difference between the readings was not provided.The reporter claimed the patient's blood glucose is usually measured at around "120 mg/dl".The patient manages her diabetes self-adjusted doses of insulin (type not reported) it was not reported if the patient made any changes to her usual diabetes management regimen in response to the alleged inaccurate results.The reporter claimed that an unspecified time after the alleged issue began, the patient¿s ¿body had a tremble¿.The reporter claimed the patient took candy as self-treatment for the symptom.Troubleshooting was unable to be performed.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.

• Brand Name: OT VERIO IQ 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: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7653705
• MDR Text Key: 112839858
• Report Number: 3008382007-2018-01847
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• PMA/PMN Number: K110637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• 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: 1-1960Z86
• 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: 06/30/2018
• 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