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

Model Number	022-657
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Deafness (1801); High Blood Pressure/ Hypertension (1908); Hypothermia (1915); Seizures (2063); Loss of consciousness (2418); Shaking/Tremors (2515); No Code Available (3191)
Date of Event	11/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a reporter for the patient (the patient¿s pharmacist) contacted lifescan (lfs) (b)(6) , alleging that the patient¿s onetouch verio 2 meter displayed inaccurately high results.The complaint was classified based on the customer service representative (csr) documentation, after additional information was obtained directly from the patient during a follow-up call on (b)(6) 2019.The patient reported that she had obtained high readings on the subject meter for about a week prior to contacting lfs.She stated that at 00:10am on november 9, 2019, she tested her blood glucose level using the subject meter and obtained a result of ¿243mg/dl¿, which, with hindsight, she considers to have been too high.The patient manages her diabetes with daily doses of 7 units of apidra and 20 units of levemir insulin.She denied making any changes to her usual diabetes management routine after obtaining the reported result.She stated that around 4am on (b)(6) 2019, she developed symptoms of ¿hypertension, hypothermia, eyesight issue, hearing issue, convulsions, trembling and a brief loss of consciousness¿ which she associated with hypoglycemia.She reported that the emergency medical services (ems) were contacted, and she received ems treatment of ¿food and/or drink¿, after which a blood glucose result of ¿120 mg/dl¿ was obtained on the ems meter.At the time of troubleshooting, the reporter confirmed that the subject meter was set to the correct unit of measure.The patient did not have control solution to test the meter and test strips and education on its use was provided by the csr.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event requiring ems intervention, after obtaining an alleged inaccurately high blood glucose result on the subject meter and continuing with her usual diabetes management routine.
Additional Manufacturer Narrative
The meter was returned to lifescan and passed performance testing.The complaint could not be confirmed.A device history record review was performed and did not identify anything during the manufacturing process that would affect product safety or performance.Lifescan conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.

• Brand Name: OT VERIO 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 9321376
• Report Number: 3008382007-2019-03807
• Device Sequence Number: 343912
• Product Code: NBW
• UDI-Device Identifier: 00353885008716
• UDI-Public: 00353885008716
• Combination Product (Y/N): Y
• PMA/510(K) Number: K131363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 4510410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2019
• Supplement Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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