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 Problems Fatigue (1849); Visual Impairment (2138)

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) (b)(4) alleging that their onetouch ping enhanced meter had a fading display.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged display issue first occurred on an unspecified date one month prior to the alert date of (b)(6) 2017.The patient manages their diabetes by self-adjusting their insulin dosage and stated that they had not made any changes to their normal diabetes management regimen as a result of the alleged product issue.The patient stated that one day after the alleged product issue they developed the symptoms of ¿very tired and vision problems¿; symptoms which they associated with having high blood glucose levels.In response to these symptoms the patient immediately self-treated by taking 14 units of lantus insulin.After this treatment, the patient measured their blood glucose on a onetouch verio flex meter and obtained a result of ¿13.9mmol/l¿ at 7pm on (b)(6) 2017.At the time of troubleshooting the csr noted that there was no misuse of the product and it was not the first time the patient had used the product.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged product issue occurred.

• 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: 6885587
• MDR Text Key: 86976927
• Report Number: 3008382007-2017-22580
• 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
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-V8URO5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2017
• Device Age: 61 MO
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2012
• 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: 53 YR