MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number	021-098
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Urinary Frequency / Polyuria (2275)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) united states, alleging that her onetouch ultra2 meter read inaccurately low compared to her feelings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that on (b)(6) 2021, she began obtaining what she felt were inaccurate low blood glucose readings in the ¿80s and 90s mg/dl¿ range with the subject meter.The patient manages her diabetes with insulin on a self-adjusting dose.The patient claimed she stopped taking her night time insulin on (b)(6) 2021 as a result of the alleged issue.The patient reported that after the alleged issue began, she developed symptom of ¿pee a lot;¿ symptom she associated with a high blood glucose.The patient denied receiving medical treatment.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 a symptom suggestive of a serious injury adverse event for hyperglycemia after obtaining alleged inaccurate low results with the subject meter.
Additional Manufacturer Narrative
The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.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.Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT ULTRA 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11867469
• Report Number: 3008382007-2021-04154
• Device Sequence Number: 14303232
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: 00353885000277
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 021-098
• Device Catalogue Number: 021-098
• Device Lot Number: 4591066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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
• Patient Age: 67 YR
• Patient Weight: 118