MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA MINI METER; GLUCOSE MONITORING SYS/KIT

Model Number	021-924
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Syncope/Fainting (4411)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that his onetouch ultramini meter read inaccurately high compared to his feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred around (b)(6) 2020.The patient reported obtaining alleged inaccurate high blood glucose readings of ¿130, 352, 401 and 481 mg/dl¿ with the subject meter.The patient stated that he manages his diabetes with unspecified insulin on a self-adjusting dose.In response to the alleged issue, the patient reported administering 12 units of insulin on (b)(6) 2020 then ¿fainted.¿ the patient claimed he was taken to hospital where his blood glucose tested ¿40 mg/dl¿ (device not specified).The patient claimed he was treated in hospital with glucose and was advised to administer insulin according to medical recommendation.The patient reported that prior to being released from hospital, his blood glucose tested ¿123 mg/dl¿ (device not specified).Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after taking insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT ULTRA MINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11011628
• Report Number: 3008382007-2020-04075
• Device Sequence Number: 17267224
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 021-924
• Device Catalogue Number: 021-924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention