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

Lot Number	5719125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Malaise (2359); Presyncope (4410)
Date of Event	02/01/2024
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.In addition, similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.
Event or Problem Description
On(b)(6) 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio iq meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation, and on additional information obtained by the medical surveillance specialist after reviewing the call recording.It was not reported when the alleged meter inaccuracy began.The patient reported obtaining what she felt were inaccurate erratic blood glucose readings of ¿116, 202 and 50 mg/dl¿ with the subject meter.The patient stated that she does not take any medication to manage her diabetes and denied making any changes to her usual diabetes management routine in response to the reported issue.The patient stated that on one occasion last week, around 1 and a half hours after obtaining the ¿202 mg/dl¿ reading, she experienced symptoms of ¿dizziness, felt unwell and felt about to pass out".10 minutes after the onset of symptoms, the patient claimed she re-tested her blood glucose with the subject meter and obtained the reading of ¿50 mg/dl¿.The patient indicated that she treated herself with sugar and sought medical attention.The patient reportedly was taken to hospital where she obtained a blood glucose result of ¿102 mg/dl¿ on the hospital meter on arrival, and received intravenous rehydration.At the time of troubleshooting, the cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca walked the patient through a control solution test and the result fell within the specified control solution range.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute complication of diabetes by an hcp after obtaining alleged inaccurate erratic blood glucose readings with the subject meter.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT VERIO IQ METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; 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: 18727941
• Report Number: 3008382007-2024-00013
• Device Sequence Number: 5587064
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: 00353885008402
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 02/16/2024

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 Lot Number: 5719125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 02/16/2024
• 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
• Patient Sex: Unknown