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

Lot Number	5807938
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/15/2024
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.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.
Event or Problem Description
On september 16, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio flex meter read inaccurately low compared to a hospital meter.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist (mss) after reviewing the call recording, since the patient disconnected the call and declined to provide further information.The patient reported that on (b)(6) 2024, at 6:00 pm, she went to the emergency room (er) at the hospital as she had ¿low blood sugar¿ and could not get her blood sugar up.It was not reported if the patient developed any physical symptoms.Upon arrival after, the patient claimed her blood glucose had risen and a reading of ¿168 mg/dl¿ with the subject meter compared to ¿197 mg/dl¿ on the er meter was obtained.The patient claimed she was administered an ¿iv bag¿.Prior to attending er, the patient indicated that her blood glucose had risen from ¿23 mg/dl¿ to ¿71 mg/dl¿ on the subject meter and that she had taken orange juice and a total of 7 glucose tablets.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the correct testing process was being followed.The cca confirmed the test strips were in good condition.The cca walked the patient through a control solution test and the result fell within the specified control solution range.This complaint is being reported because the patient reportedly received medical intervention for an acute complication of diabetes while using the product.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO FLEX 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: 20328563
• Report Number: 3008382007-2024-00045
• Device Sequence Number: 9592457
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150214
• 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): 09/27/2024

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: 5807938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/27/2024
• 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