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

Lot Number 4097585

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Syncope (1610); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verioiq meter was ¿no longer giving alerts for low sugar.¿ the complaint was classified based on the customer service representative (csr) documentation and on additional information obtained by the medical surveillance specialist (mss) after reviewing the call.The patient reported that the alleged issue began on (b)(6) 2017.The patient claimed obtaining a blood glucose reading of ¿45 mg/dl¿ which the subject meter failed to ¿flag as low.¿ the patient manages her diabetes with self-adjusted insulin (unspecified type and dose) and claimed that she exercised in response to the alleged issue.The patient reported that 3 to 4 days after the alleged issue began, she developed the symptoms of feeling ¿shaky and faint.¿ the patient advised that she self-treated her with glucose tablets.At the time of troubleshooting, the csr established that ¿pattern messages¿ were switched on in the subject meter settings.The csr also confirmed that the high-low limits had been set to the patient¿s desired range (results of ¿= 145 mg/dl¿ to be flagged as ¿high¿ and results of ¿= 85 mg/dl¿ as ¿low¿) and that these limits had not been recently changed.The csr walked the patient through a retest; however, the alleged issue remained unresolved.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 after the alleged product issue began.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter failed testing.The reported issue was confirmed.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

Manufacturer Narrative

Further 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 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: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6430868
• MDR Text Key: 70737707
• Report Number: 3008382007-2017-14088
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008402
• UDI-Public: (01)00353885008402
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4097585
• Other Device ID Number: 1-1960Z86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/07/2017
• Device Age: 28 MO
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2017; 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 109