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 Code	Insufficient Information (4580)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2024, a pharmacist contacted lifescan (lfs) france on behalf of the lay user/patient, alleging that the patient¿s onetouch verio reflect meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation, since the patient could not be contacted for additional information.It was not reported when the alleged meter inaccuracy began.The reporter claimed the patient obtained an inaccurate high blood glucose reading of ¿242 mg/dl¿ with the subject meter.In response to the elevated reading, the reporter claimed the patient administered an increased dose of insulin and as a result was rushed to hospital and was hospitalized.The reporter was unable to confirm the symptoms experienced nor the treatment received.At the time of troubleshooting, the reporter was unable to provide any information about the patient¿s testing technique or condition of the test strips.Replacement products were provided.This complaint is being reported because the patient reportedly required hospitalization after taking extra insulin based on an alleged inaccurate high result obtained with the subject meter, and it is not known what medical treatment the patient received.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; dammstrasse 19; 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: 19988085
• Report Number: 3008382007-2024-00039
• Device Sequence Number: 20929474
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/14/2024
• 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
• Patient Sex: Unknown