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	Dyspnea (1816); Fatigue (1849); Hypoglycemia (1912); Dizziness (2194); Pallor (2468)
Date of Event	11/06/2021
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)(4) alleging that the patient¿s onetouch ultra mini meter read inaccurately high compared to another device (ultra mini).The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy occurred on (b)(6) 2021 at around 4:00 pm.The reporter claimed the patient obtained blood glucose readings of ¿167 mg/dl¿ with the subject meter and ¿117 mg/dl¿ on the other device, performed 1 minute apart.The patient manages his diabetes with a combination of long- and fast-acting insulin and oral medication.The reporter claimed that 7-10 minutes after the alleged issue occurred, the patient administered a correction dose of 6 units of fast-acting insulin in response to the ¿167 mg/dl¿ reading.The reporter stated that around 4:12 pm, the patient developed symptoms of feeling ¿weak, breathless, presented pale skin/face and had dizzy legs;¿ symptoms he associated with hypoglycemia.The reporter claimed that 5 minutes after the onset of symptoms, the patient¿s family helped treat him with food and drink and within minutes he started to feel better.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 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 after administering insulin based on an alleged inaccurate high result obtained with the subject meter.
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.In addition, 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.

• 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
• 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: 12833259
• Report Number: 3008382007-2021-04274
• Device Sequence Number: 14584880
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 4656191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/17/2021
• 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; Required Intervention
• Patient Sex: Unknown