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

Model Number	022-275
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Shaking/Tremors (2515)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) united states, alleging that his onetouch verio iq meter read inaccurately high compared to his feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on the evening of (b)(6) 2021.The patient reported obtaining alleged inaccurate high blood glucose readings of ¿170 and 290 mg/dl¿ with the subject meter.The patient stated that he manages his diabetes with long- and short-acting insulin (self-adjuster) and took 5-6 units of insulin (type not reported) in response to the ¿290 mg/dl¿ reading.On the evening of (b)(6) 2021, after the insulin was administered, the patient claimed he began to feel symptom of ¿body shaking¿ and obtained a reading of ¿65 mg/dl¿ with the subject meter.The patient was unwilling to specify the treatment received.No other device was used for testing.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted 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 administering insulin based on an alleged inaccurate high result obtained with the subject meter.
Additional Manufacturer Narrative
This supplemental is being sent to include the investigation conclusion code that was omitted from the h6 field of the initial report.The investigation conclusion code that should have been included at the time of submission of the initial report is: 67.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 IQ METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12356957
• Report Number: 3008382007-2021-04222
• Device Sequence Number: 11975263
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K110637
• 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): 08/23/2021

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: 022-275
• Device Catalogue Number: 022-275
• Device Lot Number: 4603831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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