MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONE TOUCH LANCING DEVICE; GLUCOSE MONITORING SYS/KIT

Device Problem Defective Component (2292)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515); No Code Available (3191)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/ patient contacted lifescan (lfs) usa alleging that the lancet holder for her onetouch lancing device was damaged.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged product issue first started at an unspecified date and time when the lancet holder of her onetouch lancing device became damaged.The patient alleged that ¿a piece of it fell off¿, preventing her from performing a blood glucose test.The patient did not provide any information on her normal diabetes management routine and did not state if she took any action beyond her normal diabetes management routine in response to the alleged product issue.The patient reported that at an unspecified time after the start of the alleged product issue she developed the symptoms of ¿feel low, shaking and irritable¿.She did not state if she received any treatment for these alleged symptoms.During troubleshooting the csr verified that this was not the first time the patient had used the subject lancing device.The csr was unable to proceed any further with troubleshooting as the patient ¿was in a rush¿.Replacement products were sent to the patient.This complaint is being reported because the patient allegedly developed symptoms suggestive of a serious injury adverse event after not being able to perform a blood glucose test due to the lancet holder of her onetouch lancing device becoming damaged.

• Brand Name: ONE TOUCH LANCING DEVICE
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8730489
• MDR Text Key: 149062569
• Report Number: 3008382007-2019-02399
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/25/2019
• 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 Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 87