MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL UNKNOWN METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4378203

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Sweating (2444)

Event Date 05/05/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging a meter casing issue with her unknown meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that the subject meter was drooped and destroyed at 8:30am on (b)(6) 2018; no meter name or serial number was provided.The patient manages her diabetes with a combination of insulin and oral medication; she indicated that she also has cancer.She reported that as a result of the meter being damaged, she was unable to test her blood glucose levels.She reported that the week after the meter was broken, she developed ¿perspiration¿ which she self-treated with gatorade and bread at 7pm on (b)(6) 2018.She denied using any other device to check her blood glucose levels.The issue could not be resolved with troubleshooting.A replacement meter was sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event, i.E.Perspiration, after breaking her meter and being unable to test her blood glucose levels.

• Brand Name: UNKNOWN METER
• 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: 7734181
• MDR Text Key: 115523080
• Report Number: 3008382007-2018-02166
• Device Sequence Number: 0
• Product Code: CGA
• Combination Product (y/n): Y
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Device Operator: Lay User/Patient
• Device Lot Number: 4378203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/25/2018
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention