MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA TEST STRIPS; GLUCOSE MONITORING SYS/KIT

Lot Number 435719

Device Problem Bent (1059)

Patient Problems Dizziness (2194); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2017 the lay user/patient contacted lifescan (lfs) alleging an issue with her onetouch ultra blue test strips.The complaint was classified based on the customer service representative (csr) documentation and additional information obtained when the medical surveillance specialist listened again to the call recording.The patient stated that the alleged issue began around 1 month ago, however could not remember the specific date or time when she noted that approximately half of the test strips were bent in the vial she received from the pharmacy.The patient manages her diabetes using lantus insulin (self-adjusts) and she reportedly decreased her food/drink consumption and took insulin at the time the product issue occurred.The patient claimed experiencing symptoms of ¿shaking, dizzy and light-headed¿ an unspecified amount of time after the alleged issue began, and reportedly visited the hospital where she received hcp treatment of ¿sweet food and apple juice¿ in response to the reported issue.The patient confirmed that her blood glucose was not measured using any other device at the time.The csr was unable to resolve the issue during troubleshooting.Replacement products have been sent to the patient.This complaint is being reported because the patient reportedly received hcp treatment / medical intervention for an acute low blood glucose excursion after the patient was unable to test with the subject device and took insulin.The alleged strip issue could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA TEST STRIPS
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6998549
• MDR Text Key: 90935774
• Report Number: 3008382007-2017-23091
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885009713
• UDI-Public: (01)00353885009713(10)435719(17)190101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 435719
• Other Device ID Number: 1-AV-1546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2017
• Date Manufacturer Received: 10/23/2017
• 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; Required Intervention