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

Lot Number 3653423

Device Problem Peeled/Delaminated (1454)

Patient Problems Fainting (1847); Sweating (2444)

Event Type  Injury  

Manufacturer Narrative

Follow-up # 2 ¿ (09/18/2014).The lay user/patient¿s test strips have been returned on 09/11/2014 and evaluated by lifescan product analysis on 09/12/2014 with the following findings: the test strips were tested and the primary complaint was not confirmed.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At this time, lifescan considers this matter closed.

Event Description

On (b)(6) 2014, the lay user/patient contacted lifescan (lfs) usa alleging that their onetouch verioiq meter displayed an error message.In addition, the patient reported that their onetouch verio strips were peeling after being inserted in to the meter.The complaints were classified based on the customer care advocate (cca) documentation.The patient was not able to confirm when the error message began to appear or when the strip issue began.It is not known if the error message began to appear at the same time the peeling strip issue began to occur.The patient manages their diabetes with oral medication(s) as well as with diet and/or exercise.The patient denied taking any action in response to their regular diabetes management regimen routine as a result of the product issue.The patient reported that approximately 20 minutes after the product issue first occurred the patient experienced the symptoms of ¿sweaty and light headed¿.It is not known what medical treatment, if any, the patient received in response to the symptoms.The patient denied receiving treatment due to the reported product issues.At the time of troubleshooting the cca noted that the patient was unable/unwilling to walk through a retest.Replacement products were sent to the patient.These complaints are being reported because the patient reportedly developed symptoms suggestive of a serious injury after the alleged meter and test strip issues began.

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.

Manufacturer Narrative

Follow-up # 1 ¿ (09/08/2014).The lay user/patient¿s meter has been returned on 08/28/2014 and evaluated by lifescan product analysis on 09/02/2014 with the following findings: error message is observed in the error log, but error was not reproduced during the investigation.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 VERIO IQ 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: 4039502
• MDR Text Key: 12174825
• Report Number: 2939301-2014-21933
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3653423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2014
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 76 YR
• Patient Weight: 52