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 Code	Extreme Exhaustion (1843)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
On (b)(6) 2021, the reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch ultra mini meter read inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation.The reporter alleged that the inaccuracy issue started on (b)(6) 2021, in the morning.The reporter noticed that his sister was ¿falling asleep¿ and was ¿semiconscious¿.In response to the symptoms, the patient tested with the subject meter and obtained a reading of ¿81 mg/dl¿.The reporter did not specify how his sister manages her diabetes and did not report whether she made any changes to her usual diabetes management regimen in response to the issue.The reporter stated that he called the ambulance, and the patient went to the hospital where the hcp performed a blood glucose test on an ambulance meter and received a reading of ¿37 mg/dl¿.The patient was treated with iv fluids and a ¿sugar tube¿.The reporter claimed that his sister stayed in the hospital for 7 hours and is now feeling ok.During troubleshooting, the cca established that the patient was following the correct testing procedure.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.Replacement products were sent to the patient.Even though the patient developed symptoms prior to the product issue, this complaint is being reported because the patient developed signs and/or symptoms indicative of a serious injury adverse event and reportedly received hcp treatment for an acute low blood glucose excursion while using the product and the subject meter could not be ruled out as a cause or contributor to the event.

• 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 12756312
• Report Number: 3008382007-2021-04265
• Device Sequence Number: 4326102
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): N
• PMA/510(K) Number: K061118
• 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
• Report Date (Section B): 11/04/2021

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
• Device Lot Number: 4587132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Female