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

Model Number	022-659
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Diaphoresis (2452); Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verio2 meter was reading inaccurately compared to their feelings and/or normal results.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and additional information obtained when the medical surveillance specialist (mss) listened to the call recording.The patient was unable to recall the date/time that the alleged inaccuracy issue began; however, stated it was approximately 3 months prior to contacting lifescan.The patient was unable to recall exact results obtained; however, advised the cca that the results were ¿sometimes too high or sometimes too low.¿ the patient manages their diabetes with oral medication (metformin, unspecified dose) and denied making any changes to their usual diabetes management regimen in response to the alleged issue; advising that they continued to take their oral medication as prescribed.The patient reported during the call that on an unspecified date after the alleged inaccuracy issue began, they developed symptoms of feeling ¿shaky¿ and that they had ¿cold sweats¿.The patient reported that they tested their blood glucose using the subject device at the onset of symptoms and claimed obtaining readings that were ¿normal¿; however, exact readings were not recalled by the patient.In response to the symptoms they had developed, the patient reported that they called an ambulance and that they were subsequently admitted to hospital where they were treated with a ¿drip¿ to lower their blood glucose levels.The patient was unable to recall specific details relating to treatment and/or blood glucose readings obtained whilst at hospital.The patient advised that they remained in hospital for a ¿couple of days¿ before being discharged.At the time of troubleshooting, the patient was unable/unwilling to confirm if the unit of measure was set correctly at the time of testing.The cca was unable to establish if the test strips had been stored properly, were open beyond their discard date of if they had expired as the patient no longer had the subject test strips available.Replacement products were sent to the patient.This complaint is being reported because the patient was reportedly hospitalized and received treatment from a healthcare professional for an acute high blood glucose excursion after the alleged inaccuracy issue began.

• 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
• MDR Report Key: 14335946
• Report Number: 2939301-2022-03034
• Device Sequence Number: 6323152
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown