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

Lot Number	4773430
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that his onetouch verio iq meter would not power on.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that on (b)(6) 2024, at 10:00 pm, he was feeling ¿really bad and nauseous¿.In response to the symptoms, the patient claimed he attempted to test his blood glucose with the subject meter but was unable to obtain a reading due to the alleged power issue.As a result, the patient stated that he went to the urgent care clinic where he received a blood glucose result of ¿532 mg/dl¿ on the clinic meter and was treated with 10 units of admelog insulin and intravenous fluids at 11:00 pm.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and that there was no indication of misuse of the device.The cca confirmed the correct test strips were being used for testing.The cca noted that the patient no longer had the subject meter as it had been discarded.A replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute complication of diabetes after they were unable to test their blood glucose due to the reported issue.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.

• Brand Name: OT VERIO IQ 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: 19464767
• Report Number: 3008382007-2024-00027
• Device Sequence Number: 3394368
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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
• Device Lot Number: 4773430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/04/2024
• 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: Required Intervention
• Patient Sex: Unknown