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

Model Number	023-878
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the reporter (a sales representative) of the patient/lay user contacted lifescan (lfs) spain alleging that the patient¿s onetouch verio reflect meter read inaccurately low compared to a laboratory test.The complaint was classified based on the customer care agent (cca) during the initial call, since the patient was unable to be reached by phone for follow-up questions.The reporter did not specify when the alleged issue started.The reporter stated that the patient received a low blood glucose reading of ¿20/30 mg/dl¿ on the subject meter.The reporter did not have information about how the patient usually manages their diabetes nor whether the patient took any actions based on the low reading received on the subject meter.At an unspecified time, the patient started to feel ¿dizzy¿ and was brought to the hospital for unspecified treatment.The reporter informed the cca that a laboratory test was done at the hospital and a blood glucose reading of ¿300 mg/dl¿ was obtained.During troubleshooting, the cca established that the test strips had been stored properly, were not open beyond their discard date and had not expired.The cca replaced the products.Medical surveillance was unable to reach the patient to clarify if they believed the device contributed to the adverse event.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and reportedly received hcp treatment while using the product.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: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 16483144
• Report Number: 2939301-2023-00008
• Device Sequence Number: 7737779
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/03/2023

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: 023-878
• Device Lot Number: 5633662
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Unknown