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

Model Number	022-659
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Lethargy (2560)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient/lay user contacted lifescan (lfs) usa alleging that her onetouch verio 2 meter read inaccurately high compared to her feelings and/or normal results.The complaint was classified based on the customer care agent (cca) documentation.The patient alleged that the subject meter has been giving different readings for 3 weeks prior to the call with lfs.The patient reported obtaining an alleged inaccurate high blood glucose reading of ¿367 mg/dl¿ with the subject meter on (b)(6) 2022 at 12:39 pm.The patient manages her diabetes with pills (10 mg gliclazide) with diet and/or exercise and claimed that she increased her medication with another dose of 10 mg gliclazide in response to the alleged issue.The patient also indicated that she drank water.That same day at 3:20 pm, the patient developed symptoms of ¿shaking and feeling sleepy¿ and she obtained another reading on the subject meter of ¿169 mg/dl¿.The patient denied receiving any medical treatment for the reported symptoms.During troubleshooting, the cca noted that the subject meter was set to the correct unit of measure.However, the patient informed the cca that the test strips she was using were expired on (b)(6) 2021.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca educated the patient on how to use the control solution.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 diabetes medication based on alleged inaccurate high results obtained with the subject meter.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The lay user/patient¿s meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.Further analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 15033769
• Report Number: 3008382007-2022-04327
• Device Sequence Number: 5102385
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/26/2022

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: 4575113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female