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

Lot Number 3943178

Device Problem Filling Problem (1233)

Patient Problem Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Lifescan (lfs) has requested return of the subject product(s) for evaluation.If the product(s) are returned, lfs will evaluate it/them and inform fda of product(s) that do not pass inspection in a supplemental report.

Event Description

On may 24, 2016 lay user/ patient contacted lifescan (lfs) and alleged their one touch ultramini test strips would not fill.The complaint was classified based on the customer care advocate (cca) documentation.The cca was advised by the patient that the issue occurred on (b)(6) 2015.The patient stated they manage their diabetes with insulin (self-adjuster).The patient confirmed that they did make changes to their usual diabetes management regimen in response to the alleged product issue; the patient alleged exercising for a year.The patient claims they developed symptoms of ¿blurry vision¿ after the product issue on (b)(6) 2016.The patent alleged hcp treatment of insulin at the emergency room (er).The patient alleged a blood glucose results of "300mg/dl" was observed emergency medical service meter.At the time of trouble shooting, the cca confirmed this was the first time the product was being used, the patient test steps were correct, the correct test strips were being used and the test strip did not fully draw in the sample.The cca walked through a retest and the issue was not resolved replacement products were sent to the patient.This complaint is being reported because the patient allegedly developed symptoms suggestive of a serious injury after the alleged issue began.

• Brand Name: OT ULTRAMINI 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: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 5687611
• MDR Text Key: 46162664
• Report Number: 3008382007-2016-26333
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K061118
• 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: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3943178
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2016
• Date Manufacturer Received: 05/24/2016
• 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 Age: 58 YR
• Patient Weight: 37