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

Model Number	021-212
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Diaphoresis (2452); Increased Appetite (4570)
Date of Event	07/04/2022
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) 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
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern PA 19355
• 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: 15009252
• Report Number: 3009698388-2022-00028
• Device Sequence Number: 20547094
• Product Code: NBW
• UDI-Device Identifier: 00353885011464
• UDI-Public: 00353885011464
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 021-212
• Device Catalogue Number: 021-212
• Device Lot Number: 4807106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 07/13/2022
• 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: Life Threatening
• Patient Sex: Unknown