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	Fatigue (1849); Visual Impairment (2138); Dizziness (2194)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that their onetouch ultra mini meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient was unable to recall when the alleged meter inaccuracy began.The patient reported that on one occasion 3 weeks prior to contacting lfs (date not reported), they obtained an alleged inaccurate high blood glucose reading of ¿400 mg/dl¿ with the subject meter.The patient manages their diabetes with intermediate and fast-acting insulin on a self-adjusting dose.In response to the elevated reading, the patient reported administering an unspecified dose of insulin.After the insulin was administered, the patient claimed they developed symptoms of ¿dizziness¿, ¿weakness¿ and their ¿vision was affected.¿ the patient claimed they consumed food/drink as treatment.No other device was used for testing.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering insulin based on an alleged inaccurate high result 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: 11773697
• Report Number: 3008382007-2021-04145
• Device Sequence Number: 3437672
• 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): 05/04/2021

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: 04/29/2021
• Initial Report FDA Received Date: 05/04/2021
• 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