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	Dizziness (2194)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the reporter (a sales representative) of the patient/lay user contacted lifescan (lfs) spain alleging that the patient¿s onetouch verio reflect meter read inaccurately low compared to a laboratory test.The complaint was classified based on the customer care agent (cca) during the initial call, since the patient was unable to be reached by phone for follow-up questions.The reporter did not specify when the alleged issue started.The reporter stated that the patient received a low blood glucose reading of ¿20/30 mg/dl¿ on the subject meter.The reporter did not have information about how the patient usually manages their diabetes nor whether the patient took any actions based on the low reading received on the subject meter.At an unspecified time, the patient started to feel ¿dizzy¿ and was brought to the hospital for unspecified treatment.The reporter informed the cca that a laboratory test was done at the hospital and a blood glucose reading of ¿300 mg/dl¿ was obtained.During troubleshooting, the cca established that the test strips had been stored properly, were not open beyond their discard date and had not expired.The cca replaced the products.Medical surveillance was unable to reach the patient to clarify if they believed the device contributed to the adverse event.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and reportedly received hcp treatment while using the product.The subject meter could not be ruled out as a cause or contributor to the event.
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.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.
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: 16483138
• Report Number: 3008382007-2023-00007
• Device Sequence Number: 12697155
• Product Code: NBW
• UDI-Device Identifier: 00353885011709
• UDI-Public: 00353885011709
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 06/21/2023

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: 023-878
• Device Lot Number: 5633662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/21/2023
• 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: Hospitalization; Life Threatening
• Patient Sex: Unknown