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

Device Problem Image Resolution Poor (1306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Device evaluation: the lay user/patients meter has been returned and evaluated by lifescan product analysis with the following findings: the meter failed testing.The reported issue was confirmed; the meter was found to have a faded display.The lay user/patient contacted lifescan (b)(4), on (b)(6) 2017, alleging that their onetouch ping enhanced meter had a faded display.This complaint was initially ruled out because there was no indication to reasonably suggest that the product malfunctioned during customer service troubleshooting and there was also no allegation of an adverse event as a result of the reported issue.

• Brand Name: OT PING 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: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7107507
• MDR Text Key: 94974400
• Report Number: 3008382007-2017-23548
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-V8URO5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2017
• Device Age: 47 MO
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2013
• 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