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

Model Number	022-657
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dysphasia (2195)
Date of Event	01/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a healthcare professional contacted lifescan (lfs) france on behalf of the lay user/patient, alleging the patient¿s onetouch verio2 meter read inaccurately high compared to their normal readings.The complaint was classified based on the customer care agent (cca) documentation.The reporter claimed the alleged meter inaccuracy began on the morning of (b)(6) 2023.No specific readings were provided.The patient manages their diabetes with insulin.In response to the alleged issue, the patient¿s insulin dose was reportedly increased by 2 units every 48 hours.The reporter claimed that 11 days after the alleged issue began, the patient experienced hypoglycemia with symptoms of ¿troubles while talking, heavy mouth¿.Emergency medical services (ems) were reportedly notified for assistance.The reporter claimed that when ems arrived, they measured the patient¿s blood glucose with the ems meter and received a result of "34 mg/dl" and administered a glucagon injection.Replacement products were provided.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after obtaining alleged inaccurate high results with the subject device.
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: 16330051
• Report Number: 3008382007-2023-00004
• Device Sequence Number: 6873369
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131363
• 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): 02/08/2023

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 Model Number: 022-657
• Device Catalogue Number: 022-657
• Device Lot Number: 5613955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/08/2023
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown