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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Renal Failure (2041)

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra meter read inaccurately low compared to her feelings and/or normal readings.The complaint was classified based on the customer service representative (csr) documentation and on additional information obtained by the medical surveillance specialist after reviewing the call recording since the patient was unable to be reached by phone for additional information.The patient reported that on (b)(6) 2017 at 6:00 am she obtained an alleged inaccurate low blood glucose reading of ¿28 mg/dl¿ with the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine the possibility of inaccuracy.The patient informed the csr that she manages her diabetes with oral medication (metformin and glipizide twice daily), diet and exercise.The patient did not report making any changes to her usual diabetes management regimen in response to the low result and denied developing any symptoms due to the alleged issue.The patient reported that an ambulance was contacted for assistance when the alleged issue occurred and that she was taken to hospital where she was treated with iv insulin.During the call, the patient stated she also received blood as her ¿kidneys collapsed¿.The patient stated she remained in the intensive care unit for 12 days and is now in a nursing home because she ¿fell¿.The patient¿s blood glucose was measured on the hospital device at an unspecified time on (b)(6) 2017 but the results were not reported.During troubleshooting, the csr confirmed the patient was testing with test strips that appeared in good condition, were not expired or opened past their discard date.The csr noted the patient did not have control solution available to test the subject meter.The subject products were replaced and requested back for evaluation.This complaint is being reported because the patient reportedly received medical treatment for an acute high blood glucose excursion after obtaining the alleged inaccurate low result with the subject meter.

• Brand Name: OT ULTRA 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: 6405088
• MDR Text Key: 69946330
• Report Number: 3008382007-2017-12305
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-AV-1086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2017
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 64