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	Dizziness (2194); Syncope/Fainting (4411)
Date of Event	06/07/2023
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, lifescan conducted a strip lot evaluation and concluded that no other complaints were associated to this lot and thus no escalation is required and no systemic issue was observed.
Event or Problem Description
On june 09, 2023, the lay user/patient contacted lifescan (lfs) portugal, alleging that his onetouch verio 2 meter was reading inaccurately high compared to his feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient alleged that the issue started on (b)(6) 2023, when he received three blood glucose readings, before and after dinner, all above ¿240 mg/dl¿ with the subject meter.The patient indicated that he felt that the readings were not accurate but due to a heart surgery recently, he trusted the results.The patient manages his diabetes with unspecified insulin (self-adjusting dose ¿ usual dose between 14-16 units) and claimed that he increased his insulin intake to 20 units at 11 pm in response to the high readings.During his sleep the patient woke between 11:30 pm and 12 am to use the bathroom and started feeling ¿dizzy and fainted¿.The patient¿s wife assisted him promptly and treated him immediately with sugar packets.The patient indicated that he started to feel normal after.During troubleshooting, the cca was not able to confirm if the unit of measure was set correctly on the subject meter.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter and reportedly received medical intervention.

• 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: 17131860
• Report Number: 3008382007-2023-00033
• Device Sequence Number: 15067244
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 06/14/2023

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: 5643806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/14/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Male