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

Device Problem Off-Label Use (1494)

Patient Problems Sweating (2444); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 12/29/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, the patient contacted lifescan (lfs) alleging that she had had a packaging issue ¿ ultra test strips missing from her kit.The complaint was classified based on the customer care advocate (cca) limited documentation.The patient stated that the alleged missing product issue occurred on the (b)(6) 2017, the patient was unable to recall the specific time.The patient was unable/unwilling to say how she manages her diabetes or if she made any change to her usual diabetes management routine in response to the alleged product issue.The patient reported that on an unspecified time after the alleged issue began she developed the symptoms of ¿shaky, sweating and could not walk¿, the patient was unable/unwilling to say if she received any treatment.At the time of troubleshooting.When cca educated the patient on the correct contents that come with the kit, he confirmed there was missing product.The patient¿s products were replaced and requested back for evaluation.This complaint is being reported because of the delay in treatment which the patient experienced after being unable to test their blood glucose using the subject meter due to the alleged missing product.The patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event after the alleged product issue began.

• 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: 7166932
• MDR Text Key: 96443891
• Report Number: 3008382007-2018-00075
• Device Sequence Number: 1
• Product Code: CGA
• 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: Other Caregivers
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-AV-1546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/02/2018
• Date Manufacturer Received: 01/02/2018
• 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