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

Lot Number	4422961
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fainting (1847); Shaking/Tremors (2515)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter displayed inaccurately erratic blood glucose results.The complaint was classified based on the customer service representative (csr) documentation.The patient alleged that the meter started reading inaccurately from approximately 10 days prior to contacting lfs on (b)(6) 2018, at an unspecified time onward.The patient informed the csr that she manages her diabetes with a combination of diabetes medication (metformin - twice a day (1000 mg each), levemir ¿ every morning and night (dose unspecified), humalog ¿ 3 units a day).On (b)(6) 2018 around 5:30 pm the patient reportedly ¿felt a shaking sensation and passed out¿ on the same day.The patient claimed that she treated herself with 6-7 glucose tablets and reported she felt better and stable after.The patient did not report readings obtained with the subject meter from this day.On (b)(6) 2018 in the morning, the patient reported obtaining blood glucose readings of ¿512 and 430 mg/dl¿ on the subject meter, within 20 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results meets lfs¿ criteria for precision.The patient stated that due to these elevated results she increased her humalog insulin by 1-2 units in response to the elevated results.There are no further symptoms reported in response to the action taken.The patient denied using any other device to test her blood glucose.During troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject meter and an approved sample site was used to obtain the blood samples.The csr also confirmed that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The patient had followed the correct testing process, but she did not have control solution available 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 while using the product.Although the patient¿s symptoms occurred prior them obtaining the alleged inaccurate results, the alleged meter issue could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
The lay user/patient's meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter passed all testing with no faults found.The reported issue could not be confirmed.In addition, 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.Lifescan also conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.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 ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8127846
• Report Number: 3008382007-2018-03346
• Device Sequence Number: 243707
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/28/2018

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: 4422961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/28/2018
• Device Age: 19 MO
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 02/28/2019
• 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
• Patient Weight: 91