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

Lot Number	4505390
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Syncope (1610); Sweating (2444); Shaking/Tremors (2515)
Date of Event	11/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a reporter for the patient (the patient¿s wife) contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch verio reflect meter displayed inaccurately high results compared to the patient¿s feelings/normal results.The complaint was classified based on the customer service representative (csr) documentation.The reporter claimed that at 8:05 pm on (b)(6) 2019, the patient tested his blood glucose level using the subject meter and obtained a result of ¿474mg/dl¿; the patient considered this result high compared to his usual pre-evening meal result of ¿105 mg/dl¿.The patient manages his diabetes with insulin which he self- adjusts.The reporter stated that after obtaining the ¿high¿ result, the patient tested his blood glucose levels at 8:08 pm and 8:13 pm, obtaining readings of ¿463 mg/dl¿ and ¿277 mg/dl¿, respectively.The reporter indicated that at 8:13 pm, the patient administered an increased insulin dose (exact brand/dose not known by reporter).The reporter stated that sometime after administering the insulin, the patient ¿felt faint¿ with symptoms of ¿trembling and sweating¿.She reported that the patient self-treated his symptoms by consuming food/drink.At the time of troubleshooting, the reporter confirmed that the subject meter was set to the correct unit of measure.The reporter did not have control solution to test the meter and test strips and education on its use was provided by the csr.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after obtaining alleged inaccurately high blood glucose results on the subject meter and administering an increased dose of insulin.

• Brand Name: OT VERIO REFLECT METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 9309488
• Report Number: 2939301-2019-02529
• Device Sequence Number: 390542
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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 Lot Number: 4505390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2019
• 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; Required Intervention
• Patient Age: 53 YR