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

Model Number 021-212

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Increased Appetite (4570)

Event Date 07/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra easy 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 reported that the alleged meter inaccuracy began 1 week prior to contacting lfs when they opened a new vial of strips (exact date and time not communicated).The patient stated that they manage their diabetes with a fixed dose of regular insulin and denied making any changes to their usual diabetes management regimen as a result of the alleged issue.The patient reported that a few days prior to contacting lfs (exact date and time not communicated), they developed hypoglycemic symptoms of feeling ¿hungry and sweaty¿.In response to the symptoms, the patient claimed they tested their blood glucose with the subject meter and obtained an alleged inaccurate high result of ¿160 mg/dl.¿ despite the elevated reading, the patient claimed they ate food as self-treatment for the symptoms.The patient informed the cca that medical intervention was not required as generally they have a tendency of hypoglycemia.The patient denied using any other device to test their blood glucose.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.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.However, the cca noted the incorrect testing procedure was being followed.The cca educated the patient on the correct testing procedure.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA MINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 15009216
• MDR Text Key: 295857028
• Report Number: 2939301-2022-03061
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885011464
• UDI-Public: 00353885011464
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 021-212
• Device Catalogue Number: 021-212
• Device Lot Number: 4807106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening