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

Lot Number 3883956

Device Problem Calibration Error (1078)

Patient Problem Headache (1880)

Event Date 03/25/2016

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging a calcode issue with her onetouch ultramini meter.The complaint was classified based on the customer care advocate (cca) documentation and additional information obtained following a review of the call by a senior cca.The patient contacted lfs indicating that she was unable to perform a test on her meter; the issue first occurred at 5:30 pm on (b)(6) 2018.The patient stated that she is ¿borderline¿ being diabetic and does not take any medications to manage her condition.She reported, ¿i have to eat constantly¿ and further, ¿i went all day without eating and i felt that my sugar dropped¿.She reported that an hour after the start of the alleged issue, at around 6:30 pm on (b)(6) 2018, she developed a ¿real bad headache¿ which she associated with hypoglycemia.She indicated that around 7 pm on (b)(6) 2018, she ate more food to treat her symptom.During troubleshooting, the cca discovered that the patient¿s meter had been coded incorrectly.It was noted that the patient¿s test strips had expired in march 2017.The cca walked the patient through recoding the meter and the issue was resolved.The patient successfully obtained a blood glucose result.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event, i.E.Severe headache, after having difficulty obtaining a blood glucose result on her meter because it had been coded incorrectly.

• Brand Name: OT ULTRAMINI 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: 7406047
• MDR Text Key: 104667263
• Report Number: 3008382007-2018-01056
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3883956
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/26/2018
• Device Age: 33 MO
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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: 50 YR
• Patient Weight: 62