OT DELICA LANCING DEVICE

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 2020-02-04 for OT DELICA LANCING DEVICE manufactured by Lifescan Europe Gmbh.

Event Text Entries

[179327323] On january 30, 2020, the lay user/patient contacted lifescan (lfs) usa, alleging that the lancets do not fully penetrate when using her onetouch delica lancing device. The complaint was classified based on information obtained from the customer service representative (csr) documentation the patient reported that the alleged issue with the subject lancing device began at an unknown time on (b)(6) 2020. The patient manages her diabetes with oral medication (metformin, 500 mg daily) and she denied making any changes to her usual diabetes management regimen in response to the alleged issue. The patient reported that at around 10 45 a. M. , on the morning on (b)(6) 2020, she developed symptoms of? Sweating and a headache?. It is not known if the patient received treatment as a result of the alleged issue. At the time of troubleshooting, the csr noted that the patient had begun using the subject device that day. The csr confirmed that the patient was using the correct lancets, noted that the lancet gauge was 33g and confirmed that there was no misuse of the device. The csr also reviewed the patient? S sample collection technique; however, noted that the alleged issue remained unresolved. A replacement product was 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 issue with the subject device began.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008382007-2020-03861
MDR Report Key9664636
Report SourceCONSUMER
Date Received2020-02-04
Date of Report2020-01-30
Date of Event2020-01-30
Date Mfgr Received2020-01-30
Date Added to Maude2020-02-04
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 DELICA LANCING DEVICE
Generic NameGLUCOSE MONITORING SYS/KIT
Product CodeFMK
Date Received2020-02-04
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 Received2020-02-04
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-02-04

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