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

Lot Number	4412119
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Dizziness (2194); Sweating (2444)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter read inaccurately high compared to her feelings/normal results.The complaint was classified based on customer service representative (csr) documentation.The patient advised the csr that on (b)(6) 2019 at 6.00pm, she obtained an inaccurately high result of ¿197 mg/dl¿ on the subject meter, compared to her feelings/normal results.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient stated that she manages her diabetes with a combination of diabetes medications (metformin; unspecified dosage, novolog; sliding scale and levemir; unspecified dosage).She stated that, around dinner time, she took her usual dose of medication (12 units of insulin) in response to the alleged inaccurate high reading.The patient explained that on (b)(6) 2019 at 12.38am, she experienced symptoms of ¿sweaty and dizzy¿.She stated that she performed another blood glucose test and obtained a reading of ¿56 mg/dl¿ she explained that she self-treated her symptoms with a glucose tablet and a glass of orange juice immediately after becoming symptomatic.At the time of troubleshooting, the csr confirmed that the correct unit of measure was used at the time of testing.The csr confirmed that the patient¿s test strips had been stored correctly and were within expiry date.The patient did not have control solution to test the meter and test strips at the time of the initial call.Replacement products have been sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking a dose of insulin based on alleged inaccurate high results obtained with the subject meter.
Additional Manufacturer Narrative
The lay user/patients 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: 8494546
• Report Number: 3008382007-2019-00849
• Device Sequence Number: 11038887
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/27/2019

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: 4412119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2019
• Device Age: 93 MO
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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 Age: 55 YR
• Patient Weight: 95