OT VERIO IQ METER 022-275

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for OT VERIO IQ METER 022-275 manufactured by Lifescan Europe Gmbh.

Event Text Entries

[186724621] On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch verioiq meter read inaccurately high compared to her feelings and/or normal readings. The complaint was classified based on the customer service agent (csa) documentation. The patient reported that the alleged meter inaccuracy began sometime before (b)(6) 2019. The patient reported obtaining alleged inaccurate high readings in the morning of around? 185 and 189 mg/dl? With the subject meter. The patient manages her diabetes with oral medication (1 pill of glipizide twice daily). The patient claimed that sometime before (b)(6) 2019, her doctor increased her dose of glipizide to 2. 5 pills twice daily as a result of the alleged issue. The patient reported that since the increase in dose, she would wake up feeling? Shaky.? The patient indicated that when she was involved in a car accident in late (b)(6) 2019, she became of the alleged issue as her hemoglobin a1c was measured at 6. 5 % which she claimed was inconsistent with her blood glucose readings. The patient claimed that on (b)(6) 2019, her doctor changed her dose of glipizide back to 1 pill twice daily. No other device was used for testing and no additional treatment was reported. At the time of troubleshooting, the csa confirmed the unit of measure was set correctly on the subject meter. The csa 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 after the patient's hcp increased her dose of glipizide based on alleged inaccurate high readings obtained on the subject meter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008382007-2020-03887
MDR Report Key9904244
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-30
Date Mfgr Received2020-03-30
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSIMON PALMER
Manufacturer StreetBEECHWOOD PARK NORTH
Manufacturer CityINVERNESS IV2 3ED
Manufacturer CountryGB
Manufacturer PostalIV2 3ED
Manufacturer Phone1463383679
Manufacturer G1LIFESCAN SCOTLAND
Manufacturer StreetBEECHWOOD PARK NORTH
Manufacturer CityINVERNESS IV2 3ED
Manufacturer CountryGB
Manufacturer Postal CodeIV2 3ED
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameOT VERIO IQ METER
Generic NameGLUCOSE MONITORING SYS/KIT
Product CodeNBW
Date Received2020-03-31
Model Number022-275
Catalog Number022-275
Lot Number4571750
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerLIFESCAN EUROPE GMBH
Manufacturer AddressGUBELSTRASSE 34 ZUG 6300 CH 6300

Device Sequence Number: 101

Product Code---
Date Received2020-03-31
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-03-31

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