MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number	021-098
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Diaphoresis (2452); Increased Appetite (4570)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the patient contacted lifescan (lfs) us, alleging that their onetouch ultra 2 meter was reading inaccurately high.This complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged inaccuracy issue began at 01:00 on (b)(6) 2020.The patient claimed obtaining results of "556 mg/dl" (01:00, (b)(6) 2020), "181 m/dl" (02:04, (b)(6) 2020), "261 mg/dl" (08:43, (b)(6) 2020) and "204 mg/dl" (13:14, (b)(6) 2020) on the subject device.The patient manages their diabetes with oral medication ("glucozan, 5 mg", and "jardiance, 10 mg").The patient reported that she took "jardiance, 25 mg and, glucozan, 5 mg after each test taken" and that she stopped eating in response to the alleged elevated readings obtained on the subject device.The patient reported that at 02:00 on (b)(6) 2020, she became "weak", started to "sweat" and that she was "starving".The patient advised that she went to the hospital at 13:15 on (b)(6) 2020, where her blood glucose was reportedly tested at "55, 56 and 58 mg/dl" on the hospital device.The patient advised the cca that she was subsequently treated with orange juice and peanut butter crackers until her blood glucose reached "at least 90 mg/dl" during troubleshooting, the cca established that the unit of measure was set correctly on the subject device at the time of testing.The cca noted that the patient did not have control solution to perform a control solution 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 and required treatment for an acute low blood glucose excursion from a health care professional after administering medication based on the alleged inaccurately high blood glucose readings obtained on the subject device.
Additional Manufacturer Narrative
The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.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.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.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.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 2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10780018
• Report Number: 3008382007-2020-04039
• Device Sequence Number: 3657220
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: 00353885000277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 021-098
• Device Catalogue Number: 021-098
• Device Lot Number: 4613180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: Life Threatening; Required Intervention