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

Lot Number	5631730
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Hypoglycemia (1912); Diaphoresis (2452); Presyncope (4410)
Date of Event	12/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On december 5, 2023, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained when the medical surveillance specialist reviewed the call recording.During the call, the patient was unable to confirm when the alleged meter inaccuracy began.The patient stated that she manages her diabetes with oral medication (metformin 500 mg once daily).She did not report making any changes to her normal diabetes management regimen due to the alleged issue.On (b)(6), 2023, at 11:38 am, the patient claimed she woke up with hypoglycemic symptoms described as ¿sweaty, weak and felt like passing out.¿ in response to the symptoms, the patient stated that she tested her blood glucose with the subject meter and obtained back-to-back results of ¿545, 229, 217 mg/dl.¿.The tests were taken within 3 minutes of each other.The patient stated that she sat for a while and treated herself with food (peanut butter and crackers) at 11:45 am, shortly after taking the tests.The patient did not use any other device to test her blood glucose.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca determined that the same approved sample site was used for testing and that the correct testing process was being followed.The cca confirmed that the test strips were in good condition.The cca noted that 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 while using the product.The subject meter could not be ruled out as a cause or contributor to the event.
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.
Additional Manufacturer Narrative
The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.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; dammstrasse 19; 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: 18343346
• Report Number: 3008382007-2023-00073
• Device Sequence Number: 8425266
• 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,Followup
• Report Date (Section B): 06/27/2024

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: 5631730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 06/27/2024
• 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: Unknown