MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4225798

Device Problem Date/Time-Related Software Problem (2582)

Patient Problems Dehydration (1807); Fatigue (1849); Confusion/ Disorientation (2553)

Event Date 07/31/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging a date/time issue with her onetouch verio2 meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that she was going abroad the following day, so no additional follow-up was possible.The patient alleged that the subject meter had a date/time issue about a week prior to contacting lfs.It is not known what medication the patient takes to manage her diabetes or whether she made any changes to her usual diabetes management routine following the start of the alleged issue.She reported that at the same time as the issue began, she began to feel ¿disoriented and exhausted¿ on and off.She indicated that on (b)(6) 2018, she went to the emergency room and received an ¿anti-nausea fluid drip¿ because she was ¿dehydrated¿ and she reported that she was also treated with ¿iv glucose¿ at 9:45pm.During troubleshooting, the cca noted that the meter was not being used for the first time.The patient reported that the issue had not occurred after removing/replacing the battery.The cca walked the patient through resolving the issue but the issue remained unresolved.Replacement products were sent to the patient.Based on the provided information at this time, it is unclear how the date/time format issue can lead to the patient¿s symptoms since the date/time setting does not affect the ability to test.Thus, the linkage between the reported product issue and the alleged injuries by the patient, remains unclear.However, this complaint is being reported because the patient allegedly developed symptoms suggestive of serious injury adverse event requiring medical intervention, after the alleged date/time issue occurred.

• Brand Name: OT VERIO2 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: 7760829
• MDR Text Key: 116363342
• Report Number: 3008382007-2018-02237
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4225798
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/01/2018
• Device Age: 20 MO
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2016
• 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