MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4135587

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Syncope (1610); Cramp(s) (2193); Sweating (2444)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, the patient/lay user contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter was reading inaccurately high compared to another meter (ultra mini).The complaint was classified based on customer service representative (csr) documentation.The patient stated that the meter issue began sometime on (b)(6) 2018 alleging that he obtained inaccurately high blood glucose result of ¿173 mg/dl¿ on the subject meter compared to ¿53 mg/dl¿ on the other meter.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The patient stated that he manages his diabetes using insulin (self-adjuster), and in response to the alleged inaccurate high, he administered his normal dose of insulin.The patient reported that after the alleged issue (time unknown), he developed symptoms of ¿muscle cramps, sweating, not thinking clearly, and passing out¿.The patient reported that he self-treated the symptoms by drinking some orange juice.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure, and the patient had used an approved sample site to obtain the blood samples.The csr 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.It was noted the patient did not have control solution.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms of a serious injury adverse event after the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter to the event.

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.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 ULTRA2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7688507
• MDR Text Key: 114005399
• Report Number: 3008382007-2018-02011
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

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
• Device Operator: Lay User/Patient
• Device Lot Number: 4135587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/13/2018
• Device Age: 8 MO
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 07/14/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention