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

Model Number	023-878
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 march 9, 2022, the lay user/patient contacted lifescan (lfs) france, alleging that her onetouch verio reflect meter was reading inaccurately high compared to her feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged issue began on march 9, 2022.The patient claimed obtaining blood glucose readings of ¿201 mg/dl¿ at 4 am and ¿209 mg/dl¿ at 5 am with the subject meter.The patient stated that she manages her diabetes with diet and exercise and takes non-diabetes related medication (novatec, twice a day).The patient denied that she made any changes to her usual diabetes management regimen in response to the alleged issue.On that same morning, between 4 and 5 am, the patient started ¿shaking¿.The patient claimed that she got some rest, took another blood glucose test at her usual time 6:40 am and received a result of ¿230 mg/dl¿ on the subject meter.The patient informed that she ate breakfast (4 rusks with white cheese) and indicated that she felt a bit better.There was no report of any medical treatment/intervention received as a result of the alleged issue.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and that the patient was following the correct testing procedure.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.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.
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 REFLECT 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: 13745173
• Report Number: 3008382007-2022-04295
• Device Sequence Number: 17410463
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193475
• 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,Followup
• Report Date (Section B): 05/20/2022

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: 023-878
• Device Lot Number: 4793635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 05/21/2022
• 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