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

Lot Number 4420762

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Lethargy (2560)

Event Type  Injury  

Event Description

On (b)(6) 2018, the reporter contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch select simple meter was reading inaccurately high compared to their feelings and/or normal results.The complaint was classified based on customer service representative (csr) documentation.The reporter stated that the meter issue began approximately 5 days prior to them contacting lfs, alleging that the patient obtained inaccurately high blood glucose results of ¿400, 450, 520 and 480 mg/dl¿ on the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The reporter stated that the patient manages their diabetes using insulin (self-adjuster) and in response to the alleged issue, they increased their normal insulin dose from 16 units to 35 units for 4 days.The reporter alleged that approximately 4 days after the issue began, the patient developed symptoms of ¿drowsy and sleepy¿.There is no evidence the patient required or received any treatment in response to the symptoms.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure and the patient did not have control solution.The csr also noted that the patient¿s test strips and control solution, had been stored correctly, were within expiry date.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms of a serious injury adverse, whilst using the product.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT SELECT SIMPLE 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: 8063266
• MDR Text Key: 126922287
• Report Number: 3008382007-2018-03121
• Device Sequence Number: 1
• Product Code: PYV
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2018

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: 4420762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2018
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/13/2018
• 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