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

Model Number	022-275
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	06/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio iq meter was reading inaccurately high compared to her feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and additional information after cca reviewed the call.The patient reported that the alleged inaccuracy issue began at 6:05pm on (b)(6) 2021.The patient claimed obtaining a blood glucose reading of ¿138 mg/dl¿ with the subject device which he felt was inaccurately high compared to his feelings and/or normal readings.The patient manages his diabetes with oral medications and insulin and stated that he took 5mg of insulin in response to the alleged product issue.The patient reported that at 6:35pm on (b)(6) 2021, he developed symptoms ¿shakiness¿ as a result of the alleged product issue.He reported that he self-treated by consuming some food ¿ate candy¿.The patient denied that he obtained a blood glucose result on another device.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device at the time of testing, the cca also noted that at the time of the call, the reporter did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event for an acute low blood glucose excursion after administering insulin based on the alleged inaccurately high blood glucose readings obtained on the subject device.
Additional Manufacturer Narrative
This supplemental is being sent to include the investigation conclusion code that was omitted from the h6 field of the initial report.The investigation conclusion code that should have been included at the time of submission of the initial report is: 67.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO IQ METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12054644
• Report Number: 3008382007-2021-04172
• Device Sequence Number: 4411133
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K110637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 022-275
• Device Catalogue Number: 022-275
• Device Lot Number: 4669601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening