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

Model Number	023-927
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch verio reflect meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2020 at 10:00 pm.The patient claimed obtaining blood glucose readings of "235 and 155 mg/dl" with the subject meter, performed within 20 minutes of each other.The patient manages her diabetes with unspecified insulin taken twice daily (self-adjuster).The patient denied taking any action any action with regards to her usual diabetes management regimen in response to the alleged inaccurate results.The patient reported that on the evening of (b)(6) 2020, after the alleged issue began, she "lost consciousness." the patient claimed her daughter gave her jam while she was losing consciousness and contacted the emergency medical services (ems) for assistance.The patient claimed that when ems arrived, her blood glucose tested "44 mg/dl" on the ems device and that she was advised to take more sugar and bread.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca documented that the same approved sample site was used for testing and that the correct testing process was being followed.The cca confirmed that the test strips were in good condition and that the test strip vial was intact.The cca noted the patient did not have control solution available to perform a quality control test.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after obtaining alleged inaccurate results with the subject meter.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO REFLECT METER
• Common Device Name: GLUOCSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10545583
• Report Number: 3008382007-2020-03999
• Device Sequence Number: 3135099
• Product Code: NBW
• UDI-Device Identifier: 00353885011693
• UDI-Public: 00353885011693
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 023-927
• Device Lot Number: 4624798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2020
• Initial Report FDA Received Date: 09/17/2020
• 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