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 Codes	Extreme Exhaustion (1843); Hypoglycemia (1912); Dizziness (2194); Pallor (2468); Presyncope (4410)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 21, 2023, the lay user/patient¿s daughter contacted lifescan (lfs), alleging that the patient¿s onetouch verio reflect meter was reading inaccurately high.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated the patient had recently started receiving what she felt were inaccurate high readings of ¿over 300 mg/dl¿ with the subject meter.The reporter stated the patient manages her diabetes with oral medication (diabetex 500 mg, only one tablet a day because she is highly allergic).The reporter stated that on (b)(6) 2023, between 5:00 pm and 6:00 pm, the patient became scared when she received a reading of ¿317 mg/dl¿ with the subject meter and took one diabetex 500 mg tablet in response.As a result, the reporter stated the patient experienced hypoglycemia with symptoms of ¿almost became unconscious, dizzy, powerless and pale face¿ on (b)(6) 2023, between 5:00 pm and 6:00 pm.The reporter stated the patient was immediately taken to hospital by ambulance and was given ¿nitrostros¿ medication in her mouth ¿to wake her up¿.The reporter claimed a blood glucose test was performed on a neighbor¿s meter prior to receiving treatment and a reading ¿47 mg/dl¿ less than the subject meter was obtained.The exact values were not provided.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the test strips were stored correct and were not expired or opened past their discard date.The cca noted the patient 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 signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Event or Problem Description
On february 21, 2023, the lay user/patient¿s daughter contacted lifescan (lfs), alleging that the patient¿s onetouch verio reflect meter was reading inaccurately high.The complaint was classified based on the customer care agent (cca) documentation, since the reporter was unwilling to provide further information during a follow-up call.The reporter stated the patient had recently started receiving what she felt were inaccurate high readings of ¿over 300 mg/dl¿ with the subject meter.The reporter stated the patient manages her diabetes with oral medication (diabetex 500 mg, only one tablet a day because she is highly allergic).The reporter also mentioned the patient is on beta blockers.The reporter stated that on (b)(6) 2023, between 5:00 pm and 6:00 pm, the patient became scared when she received a reading of ¿317 mg/dl¿ with the subject meter and took one diabetex 500 mg tablet in response.As a result, the reporter stated the patient experienced hypoglycemia with symptoms of ¿almost became unconscious, dizzy, powerless and pale face¿ on (b)(6) 2023, between 5:00 pm and 6:00 pm.The reporter stated the patient was immediately taken to hospital by ambulance and was given ¿nitro spray¿ medication in her mouth ¿to wake her up¿.The reporter claimed a blood glucose test was performed on a neighbor¿s meter prior to receiving treatment and a reading ¿47 mg/dl¿ less than the subject meter was obtained.The exact values were not provided.The reporter indicated they attributed the onset of the patient¿s symptoms to the patient changing her normal diabetes management by taking a ¿diabetes 500 mg¿ tablet in response to the higher reading.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the test strips were stored correct and were not expired or opened past their discard date.The cca noted the patient 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 signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.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: 16475121
• Report Number: 2939301-2023-00007
• Device Sequence Number: 12594089
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 5604058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/21/2023
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown