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

Lot Number 4133063

Device Problem Image Resolution Poor (1306)

Patient Problems Sweating (2444); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) (b)(4) alleging a fading display issue with his onetouch ping enhanced meter remote.The complaint was classified based on the customer service representative (csr) documentation.The patient claimed that the meter¿s display began fading about a week prior to contacting lfs; he reported that he ¿could not read from the screen as it is getting dimmer and dimmer¿.The patient manages his diabetes with insulin pump therapy.He denied making any changes to his usual diabetes management routine as a result of the alleged issue.He reported that an unknown time after the issue began, he developed symptoms of ¿sweaty and shaky¿.He denied receiving any treatment for his symptoms beyond his usual diabetes care and management routine.At the time of troubleshooting, the csr noted that the meter was not being used for the first time and based on the information provided there had been no misuse of the product.The patient did not have a backup meter.The patient¿s products were requested back for investigation and replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event, i.E.Sweaty and shaky.After the alleged product issue began.

Manufacturer Narrative

Analysis was not possible for the returned meter due to unknown storage and handling preventing the allegation being physically investigated.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6607247
• MDR Text Key: 76495015
• Report Number: 3008382007-2017-21409
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4133063
• Other Device ID Number: 1-V8URO5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/31/2017
• Device Age: 38 MO
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 05/31/2017
• Supplement Dates FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2014
• 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
• Patient Age: 55 YR
• Patient Weight: 91