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.
Additional Manufacturer Narrative
Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.
Additional Manufacturer Narrative
Correction to block b5.The reporter was unwilling to provide further information during a follow-up call.A review of the call recording clarified the patient was given 'nitro spray' in her mouth to wake her up.The reporter also mentioned the patient is on beta blockers.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.

• 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 16475120
• Report Number: 3008382007-2023-00006
• Device Sequence Number: 15285216
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K193475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown