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

Lot Number H284381C

Device Problems Failure to Power Up (1476); Shelf Life Exceeded (1567)

Patient Problem Hyperglycemia (1905)

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 (b)(6) 2016 the lay user/patient contacted lifescan alleging that their onetouch surestep meter would not power on.The following complaint was classified based on information obtained from the customer care advocate (cca) documentation.The patient was unsure when the alleged issue began.The patient manages their diabetes with pills, diet and exercise.The patient denied making any changes to their usual diabetes management regimen in response to the alleged issue.The patient denied developing any symptoms; however, reported being admitted to hospital.The patient reported obtaining a blood glucose reading of 400 mg/dl on a hospital meter.The patient reported receiving treatment but was unable/unwilling to provide further information.At the time of troubleshooting the cca noted that the test strips had expired in 2006.Replacement products were sent to the patient.This complaint is being reported because the patient became hyperglycemic and required hcp intervention.

• Brand Name: OT SURESTEP ENHANCED 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: 5515854
• MDR Text Key: 40833951
• Report Number: 2939301-2016-13774
• Device Sequence Number: 1
• Product Code: NBW
• 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: Patient
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: H284381C
• Other Device ID Number: 1-AV-1121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2016
• Device Age: 164 MO
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2002
• 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
• Patient Age: 79 YR