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

Lot Number 4059317

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

Patient Problems Death (1802); Seizures (2063); Coma (2417)

Event Type  Death  

Manufacturer Narrative

In addition, there is also an informational insert within the system kit packaging bringing attention to the meter cal code requirement, advising the user that the meter cal code had been pre-set to cal code 25 and referring the user to the owner¿s manual for further information.The patient¿s products were requested back.This complaint is being reported because the patient reportedly obtained inaccurately high blood glucose results with the subject meter and then later experienced hypoglycemic episodes during which she ¿fainted and had seizures¿ and subsequently entered a coma from which she did not recover.The cause of death was reported as ¿diabetes and infection in the lungs¿ and the subject device could not be ruled out as a cause or contributor to the patient¿s death.A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.(b)(4).

Event Description

On (b)(6) 2017, the lay user/patient¿s daughter contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch ultramini meter was reading inaccurately high compared to another device (emergency medical services ¿ ems ¿ meter, brand not reported).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 transcript of the call recording.The reporter was unwilling to answer follow-up questions when a csr contacted her to obtain additional information on three separate occasions.The reporter advised during the initial call that the alleged inaccuracy issue had been ongoing since she bought the meter for her mother; however, she was unable to recall a specific date/time.The reporter stated that prior to obtaining the subject meter, the patient had been suffering from hypoglycemic episodes during which she ¿fainted and had convulsions¿ and that in response, the patient¿s doctor had advised her to obtain the subject meter to monitor her blood glucose.The reporter advised that the patient continued to experience hypoglycemic episodes whilst using the subject device and that on three occasions, they had contacted ems due to the patient becoming ¿unwell¿ and claimed that the results obtained on the subject meter were higher when compared to those obtained on the ems device.The reporter was unable to recall all of the results obtained on these occasions or the dates/times these comparisons were made; however, she did recall obtaining readings of ¿68 mg/dl¿ on the subject meter and ¿25 mg/dl¿ with the ems device, performed within 30 minutes of each other.It is understood that the patient managed her diabetes with insulin (type and dose not reported) and that she was taking other medications (including niacin, dose not specified) at the time of the alleged issue occurring; however, the reporter was unable to recall further information regarding these medications at the time of the initial call with the csr.The reporter denied that the patient made any changes to her usual diabetes management regimen in response to the alleged elevated readings obtained with the subject device.The reporter advised during the call that the patient ¿fainted and had seizures¿ an unknown time after the blood glucose reading of ¿68 mg/dl¿ which the patient allegedly obtained on the subject meter.The reporter informed the csr that on this occasion (date and time not reported), she contacted ems who attended within 15/20 minutes, measured the patient¿s blood glucose at ¿25 mg/dl¿ on their device and treated the patient with a glucagon injection.The patient was subsequently taken to hospital and the reporter advised that an unknown time after receiving treatment, the patient ¿went into a coma¿ and later passed away.The reporter informed the csr that she had been told by a doctor that the cause of death was ¿diabetes and an infection in the lungs¿.It is not known how long the patient had been suffering from a lung infection or if she was receiving treatment for this.The date of death was not provided.During troubleshooting of the alleged issue, the csr noted that the subject meter had been incorrectly calibrated to cal code 01 as opposed to cal code 25, as printed on the test strip vial.As per the owner¿s manual, code numbers are used to calibrate the onetouch ultramini meter with the onetouch ultra test strips in order to obtain accurate blood glucose test results.The onetouch ultramini meter must be coded before using it for the first time and again when using a different vial of test strips.

Manufacturer Narrative

Lifescan successfully followed-up with the reporter on (b)(6) 2017, and she provided the date of death as ¿(b)(6) 2017.¿ this information has been documented within this supplemental report.Lfs has yet to receive a copy of the death certificate; however, continued attempts in sourcing this have been made by means of written email, as specifically requested by the reporter.In this correspondence to the reporter, lfs also requested return of the subject products as although the reporter agreed to return them to lfs for further investigation, they have not yet been received.To further assess the inaccuracy allegation, lfs conducted testing of retained samples from the onetouch ultra test strip lot #4059317 (expiry 02/2018) using control solution.All results fell within the established control solution range for this lot.From this we can determine that, as manufactured, the strips perform as intended.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.

• 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: 6806664
• MDR Text Key: 83090849
• Report Number: 3008382007-2017-22249
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K061118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4059317
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2017
• Device Age: 11 MO
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/21/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2016
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 39