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

Model Number	022-657
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Diaphoresis (2452); Shaking/Tremors (2515); Sleep Dysfunction (2517)
Date of Event	09/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that his onetouch verio2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began at an unspecified time on (b)(6) 2020.The patient claimed obtaining blood glucose readings of "291 and 288 mg/dl" with the subject meter, performed more than 20 minutes apart.The patient stated that he usually manages his diabetes with 14 units of humalog insulin.The patient claimed he took an increased dose of 24 units of insulin on (b)(6) 2020 in response to the alleged inaccurate results.The patient reported developing symptoms of "sweating, shaking and can't sleep" at an unspecified time on (b)(6) 2020, but denied receiving medical treatment.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and that the same approved sample site was used for testing.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 after taking an increased dose of insulin based on alleged inaccurate results obtained with the subject meter.

• Brand Name: OT VERIO 2 METER
• Common Device Name: GLUOCSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10579022
• Report Number: 3008382007-2020-04004
• Device Sequence Number: 19527973
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 4638013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention