MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number	5588992
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Convulsion/Seizure (4406); Syncope/Fainting (4411)
Date of Event	08/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the lay user/patient contacted lifescan (lfs) united states, alleging that his onetouch verio2 meter read inaccurately high compared to another meter.The complaint was classified based on additional information obtained by the medical surveillance specialist after reviewing the call recording, since attempts to reach the patient by phone to obtain further information were unsuccessful.The patient reported that the alleged meter inaccuracy occurred between (b)(6), 2023.The patient reported obtaining blood glucose readings of ¿598 mg/dl¿ with the subject meter and ¿500 mg/dl¿ on the other meter (verio flex), performed within 30 minutes of each other.The patient manages his diabetes with a combination of insulin (basaglar; humalog - sliding scale based on blood glucose readings) and stated he tests his blood glucose 10-15 times a day.In response to the alleged inaccurate reading(s), the patient claimed he took an increased dose of 25 units of humalog, followed by more insulin when he continued to receive high readings, and took a total of around 40-45 units of humalog on the evening of (b)(6) 2023.As a result, the patient reported experiencing 4 "hypoglycemic attacks" over a period of 12 hours between (b)(6) 2023, and mentioned that 2 of the attacks were ¿really bad¿.He described experiencing symptoms of ¿dizziness, faint and seizures¿ requiring the assistance of a family member who treated him with orange juice with sugar as they were reportedly unable to find his glucagon nasal spray.The patient reported that when they decided to test with another box of strips, he received a blood glucose result of ¿46 mg/dl¿ (exact time not reported).At the time of troubleshooting, the customer care agent (cca) confirmed the unit of measure was set correctly on the subject meter.The cca noted an approved sample site was used for testing and the correct testing process was being followed.The cca confirmed the test strips had been stored correctly and were not expired.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 administering insulin based on alleged inaccurate high results obtained with the subject meter.
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.

• Brand Name: OT VERIO 2 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: 17638663
• Report Number: 3008382007-2023-00046
• Device Sequence Number: 7752415
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131363
• 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): 08/28/2023

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
• Device Lot Number: 5588992
• 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: 08/28/2023
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown