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

Lot Number 4041613

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

Patient Problems Twitching (2172); Loss of consciousness (2418); No Code Available (3191)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, the lay user/patient¿s daughter contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultralink meter was reading inaccurately high compared to her feelings and/or normal results.The complaint was classified based on information obtained from the customer service representative (csr) documentation.The reporter advised that the alleged issue began at around 10:45 p.M., on (b)(6) 2018.The reporter claimed that the patient obtained a blood glucose reading of ¿361 mg/dl¿ with the subject meter which the patient felt was high compared to her feelings and/or normal readings.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient manages her diabetes with insulin pump therapy and the reporter advised that in response to the alleged elevated reading obtained on the subject device, the patient administered 4.9 units of rapid acting insulin (humalog).The reporter advised that around 4 hours and 15 minutes after the alleged issue occurred, she found the patient in her bedroom ¿twisting, jerking, moaning and unresponsive¿.The reporter stated that she immediately tested the patient¿s blood glucose using the subject device and obtained a reading of ¿32 mg/dl¿.The reporter contacted paramedics who attended at approximately 3:15 a.M., on (b)(6) 2018, and took the patient to the emergency room (er).The reporter advised that the patient was admitted to the intensive care unit (icu) and treated with dextrose.The patient was reportedly due to be released from the icu on (b)(6) 2018, and the reporter stated that ¿half her mother¿s body is suffering from a mild paralysis¿.At the time of troubleshooting, the csr noted that the unit of measure was set correctly on the subject meter.The csr confirmed that the test strips had been stored properly, were not open beyond their discard date and had not expired.The csr walked the reporter through a control solution test and noted that the result obtained fell within the control solution range printed on the test strip vial.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs suggestive of a serious injury adverse event and required treatment from a health care professional for an acute low blood glucose excursion after administering insulin based on the alleged elevated blood glucose reading obtained on the subject device.

• Brand Name: OT ULTRALINK 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: 7205006
• MDR Text Key: 97712805
• Report Number: 3008382007-2018-00211
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073231
• 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: 01/05/2018

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4041613
• Other Device ID Number: 1-M5WXU9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/05/2018
• Device Age: 74 MO
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2011
• 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: 68 YR
• Patient Weight: 72