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

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Paresis (1998); Dysphasia (2195); Malaise (2359)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On september 28, 2023, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio iq meter read inaccurately compared to her 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 a few weeks prior to contacting lfs.The patient reported obtaining alleged inaccurate readings of ¿600, 20, 50 and 380 mg/dl¿ with the subject meter on unspecified dates/times.The patient manages her diabetes with a combination of diabetes medications (trulicity, weekly injection of 6 units; insulin tresiba, 34 units once per day; insulin fiasp, fixed dose 3 to 5 times per day).In response to the alleged inaccurate reading of ¿600 mg/dl¿, the patient reported taking her usual dose of tresiba insulin then later that same day started ¿feeling off, was not able to move or talk very well and was feeling like getting a stroke¿.The patient stated her doctor visited her at home and performed another blood glucose test with the subject meter and obtained a result of ¿20 mg/dl¿.The patient stated her doctor gave her something with sugar to raise her blood glucose and she felt better afterwards.The patient denied using any other device to test her blood glucose.The patient was unsure if the event was related to an inaccurate reading and overdose of insulin or to other health problems that may be affecting her blood glucose.The patient declined to troubleshoot.Replacement product was 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 treatment based on an alleged inaccurate result obtained with the subject meter.The subject meter could not be ruled out as a contributor to the event.

• 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
• 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: 17877165
• Report Number: 3008382007-2023-00053
• Device Sequence Number: 15249517
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/05/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown