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

Model Number	022-659
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
Date of Event	09/08/2022
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) 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio2 meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on further information obtained by the medical surveillance specialist after reviewing the call recording.The patient reported that the alleged meter inaccuracy began 3 weeks prior to contacting lfs.The patient reported obtaining what they felt were inaccurate high blood glucose readings of ¿145, 120, 80, 109, 108, 110, 134 and 147 mg/dl¿ with the subject meter on unspecified dates/times.The patient manages their diabetes with oral medication (metformin) and they continued to follow their usual diabetes management regimen in response to the alleged issue.The patient reported that on (b)(6) 2022, at 5:30 pm, they experienced a ¿low sugar¿ with symptoms of ¿sweating and shaking¿.The patient claimed they self-treated with orange juice.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 confirmed the test strip vial was intact and the test strips had been stored correct 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 symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.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 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: 15442745
• Report Number: 3008382007-2022-04343
• Device Sequence Number: 5582427
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131363
• 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): 03/23/2023

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 Model Number: 022-659
• Device Lot Number: 4857083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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