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

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 10/19/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) (b)(6), alleging that his onetouch verio iq meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.It was not reported when the alleged issue began.The patient claimed obtaining several blood glucose readings of ¿around 300 mg/dl¿ with the subject meter, performed within an unspecified time of each other.The patient manages his diabetes with insulin 5 times a day (humalog during the day; correction dose after 2 hours if his blood glucose is still high and protaphane at night).In response to the alleged inaccurate results, the patient claimed he administered more insulin than usual (exact amount not specified).The patient reported that an unspecified time after the alleged issue began, he became ¿hypoglycemic;¿ he reported having ¿metabolic derailment¿ and was found by his spouse ¿collapsed, lying on the floor unresponsive.¿ the patient claimed emergency medical services (ems) were contacted for assistance.When ems arrived, the patient confirmed his blood glucose measured ¿30 mg/dl¿ on the ems device.The patient indicated he drank a bottle of cola afterwards as treatment.At the time of troubleshooting, the cca confirmed the test strips were not stored correctly (per owner¿s booklet recommendation).Replacement products were unable to be sent to the patient as the patient disconnected the call.Further attempts were made to contact the patient but he declined to answer.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after taking additional insulin based on alleged inaccurate results obtained with the subject meter.

• Brand Name: OT VERIO IQ METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 12734066
• MDR Text Key: 279594047
• Report Number: 3008382007-2021-04262
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K110637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/01/2021
• 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