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U.S. Department of Health and Human Services

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

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LIFESCAN EUROPE GMBH OT VERIO REFLECT METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 4836117
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Convulsion/Seizure (4406)
Event Date 11/08/2022
Event Type  Injury  
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 Description
On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) canada, alleging that their onetouch verio reflect meter was reading inaccurately high compared to a continuous glucose monitoring device (cgm).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on the morning of (b)(6) 2022, at 11:00 am.The patient claimed obtaining a reading of ¿3.2 mmol/l¿ with the cgm device then ¿10.2 mmol/l¿ on the subject meter.The patient stated that prior to the alleged issue, they began having a seizure and proceeded to check their glucose with the assistance of a third-party (lay individual).The patient manages their diabetes with long-acting insulin (tresiba) and fast-acting insulin (admelog).When the reading of ¿10.2 mmol/l¿ on the subject meter was obtained, the patient claimed they trusted the meter and took action by administering an increased dose (15 units) of admelog insulin.At around 11:30 am that morning, the patient¿s seizure worsened, and a third-party (lay individual) treated them with glucose gel followed by honey, sugar and dextrose.The patient stated that they re-checked their glucose at 12:00 pm when they felt well, and obtained a reading of ¿5.4 mmol/l¿ with the cgm device compared to a reading which was ¿3 units apart¿ on the subject meter.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, the test strips had been stored correctly and the correct testing process was being followed.However, the patient was unable to recall if the test strip vial had been opened for longer than the 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 worsening symptoms suggestive of a serious injury adverse event after administering insulin based on an alleged inaccurate result obtained with the subject meter.
 
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Brand Name
OT VERIO REFLECT METER
Type of Device
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 Key15832645
MDR Text Key303996915
Report Number3008382007-2022-04356
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K193475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/21/2022
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
Device Operator Lay User/Patient
Device Lot Number4836117
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/08/2022
Initial Date FDA Received11/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age35 YR
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