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

Lot Number 3360972

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Headache (1880); Polydipsia (2604)

Event Date 08/19/2013

Event Type  Injury  

Manufacturer Narrative

The patient¿s meter and test strips have been returned on (b)(6) 2013 and evaluated by lifescan product analysis on (b)(6) 2013 and (b)(6) 2013, respectively, with the following findings: the meter passed all testing with no faults found. The reported issue could not be confirmed. The test strips were also tested and the primary complaint was not confirmed. If lifescan obtains additional information regarding this complaint, a follow up report will be submitted. At this time, lifescan considers this matter closed.

Event Description

On (b)(6) 2013, the lay user/patient contacted lifescan (lfs) alleging that her onetouch ultra 2 meter was reading inaccurately erratic. The complaint was classified based on the customer care advocate¿s (cca) documentation. The patient claimed the alleged issue began at approximately 5:33am on the same day she contacted lfs for assistance. She tested back to back on the subject meter and observed values of ¿142, 163 and 151 mg/dl¿ performed within 20 minutes of each other. Based on statistical methodology, the calculated difference of these glucose results falls within the expected value of <
=
20% and/ or <
=
20 mg/dl. It is not known what range the patient considers to be normal. The patient manages her diabetes with an unknown type/dose of insulin (self adjusted) and denied making any changes to her usual diabetes management routine in response to the alleged issue. The patient reported developing symptoms of dry mouth, extreme thirst and headache immediately after testing and denied receiving any form of medical treatment. At the time of troubleshooting the cca confirmed the meter was set to the correct unit of measure, the samples were obtained from the same approved sample site. The subject test strips were unexpired and stored correctly. Replacement products have been sent to the patient and subject products are pending return for investigation. This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury after the alleged meter issue began.

• 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
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 3318324
• MDR Text Key: 21310165
• Report Number: 2939301-2013-01469
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 3360972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2013
• Date Manufacturer Received: 08/19/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/30/2013 Patient Sequence Number: 1