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

Lot Number	5622800
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Diaphoresis (2452); Shaking/Tremors (2515)
Date of Event	08/02/2023
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) 2023, the lay user/patient contacted lifescan (lfs), alleging that her onetouch verio2 meter read inaccurately high compared to her feelings.The complaint was classified based on the customer care agent (cca) documentation.It was not reported when the alleged meter inaccuracy began.The patient reported obtaining high readings while she was experiencing low blood glucose symptoms.The patient claimed that on one occasion, on the morning of (b)(6) 2023, she experienced symptoms of ¿shaking and sweating¿ and received a reading of ¿15.0 mmol/l¿ with the subject meter.Despite the alleged elevated result, the patient claimed she treated herself with orange juice and felt better afterwards.The patient manages her diabetes with a combination of oral medication (diamicron) and insulin (15 units once daily before bed).It was not reported if the patient made any changes to her usual diabetes management regimen as a result of the alleged issue.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.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 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 while using the product.The subject meter could not be ruled out as a cause or contributor to the event.

• 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
• 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: 17476889
• Report Number: 3008382007-2023-00045
• Device Sequence Number: 2598500
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2023

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
• Device Lot Number: 5622800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2023
• 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: Life Threatening
• Patient Sex: Unknown