MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO FLEX METER; GLUCOSE MONITORING SYS/KIT

Model Number 023-271

Device Problem Loss of Power (1475)

Patient Problems Weakness (2145); Sweating (2444); Confusion/ Disorientation (2553); Alteration In Body Temperature (2682)

Event Date 05/17/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verioflex meter was powering off during use.The complaint was classified based on information obtained from the customer service representative (csr) documentation.The patient reported that the alleged power issue with the subject device began on the morning of (b)(6) 2020.The patient manages her diabetes with insulin (20 units of 70/30 (b)(6) brand insulin in the morning and a further 16 units in the evening; no adjustments made to dose) and she denied making any changes to her usual diabetes management regimen in response to the alleged issue.The patient reported that on (b)(6) 2020, she developed symptoms of ¿feeling weak, hot, sweaty and confused to the point that it wakes her up while she is asleep¿.The patient reported that she contacted her doctor for some medical advice and was told to drink ¿8 oz of orange juice¿ and eat some ¿peppermint candy¿.At the time of troubleshooting, the csr confirmed that the product was not being used for the first time and noted that there was no apparent misuse of the device.Based on the patient¿s testing frequency, the csr noted that the meter¿s battery did not need to be replaced.The csr educated the patient on the meter¿s behavior and auto-shutoff and the alleged meter issue remained unresolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse after the alleged power issue occurred with the subject device.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; GB IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; GB IV2 3ED ; 1463383679
• MDR Report Key: 10095189
• MDR Text Key: 193066237
• Report Number: 3008382007-2020-03937
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2020

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 Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 4600274
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2020
• Initial Date FDA Received: 05/28/2020
• 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: 86 YR
• Patient Weight: 73