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

Model Number	022-659
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anxiety (2328); Malaise (2359); Shaking/Tremors (2515)
Date of Event	06/04/2023
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, 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 june 6, 2023, the lay user/patient¿s spouse contacted lifescan (lfs) canada, alleging that the patient¿s onetouch verio2 meter read inaccurately erratic.The complaint was classified based on information obtained from the customer care agent (cca) during the initial call, since the reporter declined to provide any further information.The reporter stated that the alleged meter inaccuracy began on (b)(6) 2023, at 12:30 pm.The reporter claimed the patient obtained blood glucose readings of ¿6.1 and 7.3 mmol/l¿ with the subject meter, performed within 20 minutes of each other.The patient manages his diabetes with oral medication (januvia).As a result of the alleged issue, the reporter claimed the patient took his usual dose of medication and developed symptoms described as ¿shaking because he was scared, not well and stressed¿.The reporter indicated that it was hot outside at the time of the event.The reporter declined to provide any further information regarding the event.During troubleshooting, the cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.The reporter declined to complete the troubleshooting process.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms that could be indicative of a serious injury adverse event after obtaining the alleged inaccurate results.The reported issue could not be ruled out as a cause or contributor to the event.

• 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: 17114307
• Report Number: 3008382007-2023-00032
• Device Sequence Number: 7065731
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/12/2023

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: 022-659
• Device Lot Number: 5639528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/12/2023
• 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 Sex: Unknown