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

Lot Number	5666567
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 17, 2023, a reporter for the lay user/patient contacted lifescan (lfs), alleging that the patient¿s onetouch ultra mini meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged inaccuracy issue began 1 week prior to contacting lfs.The reporter claimed the patient obtained blood glucose readings of ¿180 and 60 mg/dl¿ with the subject meter, performed within 20 minutes of each other.The reporter stated that the patient manages his diabetes with pills and sometimes insulin if the pills do not work.The reporter denied the patient took any action in regards to his normal diabetes management as a result of the alleged issue.The reporter claimed the patient developed symptom of ¿shaking¿ at an unspecified date/time after the alleged issue began and self-treated with food and drink.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter, the same 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 available to perform a quality control test.A replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
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.

• 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: 17992915
• Report Number: 3009698388-2023-00027
• Device Sequence Number: 12632072
• 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): 10/23/2023

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 Lot Number: 5666567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 10/23/2023
• 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