MAUDE Adverse Event Report: LIFESCAN INC 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); Diaphoresis (2452); Shaking/Tremors (2515)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On april 06, 2023, the lay user/patient contacted lifescan (lfs), alleging that their onetouch ultramini meter read inaccurately high compared to another meter (accu-chek).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2023, at 12:00 am when they obtained an unspecified blood glucose reading with the subject meter.The patient manages their diabetes with oral medication (metformin) and insulin (novorapid, twice daily on a self-adjusting dose according to blood glucose readings).As a result of the alleged issue, the patient reported taking an increased dose of 4 units of novorapid insulin.The patient claimed that 3 hours after the alleged issue began, they developed symptoms of feeling ¿sweaty and shaky¿.The patient reported being treated by their spouse with a sugary drink.Prior to receiving treatment, the patient reported obtaining blood glucose readings of ¿129 mg/dl¿ with the subject meter and ¿64 mg/dl¿ on the other meter, performed less than 10 minutes apart.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted an approved sample site was used for testing and the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted the patient did not have control solution to perform a quality control test.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event the alleged inaccuracy issue began.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 INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 16719751
• Report Number: 2939301-2023-00019
• Device Sequence Number: 7454780
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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: 4828333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown