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

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Apnea (1720); Dehydration (1807); Hyperglycemia (1905); Muscle Weakness/Atrophy (1967); Pallor (2468); Polydipsia (2604); Syncope/Fainting (4411); Alteration in Body Temperature (4568)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.In addition, 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.
Event or Problem Description
On (b)(6) 2023, the lay user/patient¿s relative contacted lifescan (lfs) italy, alleging that the patient¿s onetouch verio reflect meter read inaccurately low compared to his feelings and/or normal readings and compared to an emergency medical service meter.The complaint was classified based on additional information obtained by the customer care agent (cca) during a follow-up call with the reporter.The reporter stated that on (b)(6) 2023, at 10:00 am, the patient measured his blood glucose with the subject meter in response to symptoms of ¿not feeling well¿ and obtained an alleged low result of ¿40 mg/dl¿.The reporter was unable to provide information on the specific symptoms felt at that time.The reporter mentioned that the patient is assisted daily by a carer.The reporter advised that the patient performs blood glucose monitoring once a day, 6 or 7 times a week and that he takes oral therapy (type/dose not reported) and a once daily dose of insulin to manage his diabetes.During the follow-up call, the reporter claimed that in the days prior to the alleged issue, the patient was receiving blood glucose results of around ¿380 to 400 mg/dl¿.As a result of the alleged inaccurate low reading, the reporter claimed the patient drank a glass of sugar and water at 10:05 am then at 10:30 am experienced symptoms described as ¿cold, white, apnea for a minute, urge to drink, weakness in limbs and collapsed¿.The carer called the emergency medical services (ems) for assistance.Prior to ems arriving, the reporter claimed the patient drank a glass of water to relieve his thirst.When ems arrived, the reporter claimed they measured the patient¿s blood glucose on the unspecified ems meter and a result of ¿380 mg/dl¿ was obtained.Other unspecified measurements were performed, and the patient was brought to the hospital at approximately 11:00 am.On arrival at the hospital, the reporter claimed the patient was administered saline solution and sedatives.The reporter claimed the patient received a diagnosis of ¿dehydrated and high blood sugar¿ and was hospitalized for 2 days.The reporter felt the administration of the sugar water due to the low reading could have caused and/or contributed to the patient's symptoms and hospitalization claiming, ¿the patient actually had high blood sugar¿.At the time of the follow-up call, the reporter advised that the patient was doing better but that his blood glucose levels were unstable.During troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the patient no longer had the subject vial of test strips.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, requiring hospitalization, after treatment was administered based on an alleged inaccurate low result on 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: 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: 17840499
• Report Number: 3008382007-2023-00052
• Device Sequence Number: 11626449
• Product Code: NBW
• UDI-Device Identifier: 00353885011693
• UDI-Public: 00353885011693
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 09/28/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2023
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown