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 Codes	Dehydration (1807); Diarrhea (1811); Hypoglycemia (1912); Blurred Vision (2137); Dysphasia (2195); Shaking/Tremors (2515)
Date of Event	07/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a reporter for the lay-user/patient contacted lifescan (lfs) (b)(6), alleging that the patient¿s onetouch ultra mini meter read inaccurately high compared to a hospital meter.The complaint was classified based on additional information obtained by the customer care agent (cca) during a follow-up call with the reporter.The reporter stated that on the morning of (b)(6) 2021, the patient began to develop symptoms of ¿dehydration and diarrhoea.¿ in response to the symptoms, the reporter claimed the patient took her usual dose of diabetes medication (1 pill of diamicron) but continued to feel symptomatic; symptoms of ¿lack of speech, trembling, cloudy vision, low blood glucose¿ were reported.The reporter claimed the patient was treated with liquid dextrose at 3:00 pm after obtaining blood glucose readings of ¿80 mg/dl¿ then ¿50 mg/dl¿ with the subject meter.However, the patient continued to feel bad and was taken to hospital where she obtained a blood glucose reading of ¿340 mg/dl¿ with the subject meter compared to ¿240 mg/dl¿ on the hospital meter.The readings were taken at the same time as each other.The reporter claimed the patient was treated in hospital with liquid dextrose then 9 units of insulin.The reporter stated the patient was hospitalized for 11 days and after discharge from hospital, she managed her diabetes with insulin.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the test strips had been stored correctly and were not expired or opened past their discard date.The cca walked through a control solution test and the result fell outside the specified control solution range.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event requiring medical intervention while using the product.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.This supplemental is being sent to include the investigation conclusion code that was omitted from the h6 field of the initial report.The investigation conclusion code that should have been included at the time of submission of the initial report is: 67.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At this time, lifescan considers this matter closed.

• 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
• MDR Report Key: 12334494
• Report Number: 3008382007-2021-04210
• Device Sequence Number: 4542671
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): Y
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 4639325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR