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

Lot Number	4066273
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Codes	Itching Sensation (1943); Nausea (1970); Sweating (2444)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter was reading inaccurately high compared to another onetouch ultramini.The complaint was classified based on information obtained from the customer service representative (csr) documentation, since the patient was unable to be reached by phone for additional information.The patient reported that the alleged issue began at 2 a.M., on (b)(6) 2017.The patient claimed obtaining blood glucose readings of ¿109 mg/dl¿ with the subject meter and ¿70 mg/dl¿ with the other device, performed within 30 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results exceeds lfs¿s criteria for accuracy.The patient advised that she does not take any medication to manage her diabetes and reported that approximately 10 minutes prior to obtaining the alleged inaccurately high blood glucose reading, she developed symptoms of ¿itching, sweating and nausea¿.The patient advised that she self-treated her symptoms by drinking 3 oz., of orange juice.At the time of troubleshooting, the csr noted that the unit of measure was set correctly on the subject meter, that the correct testing method was being followed and that an approved sample site was used to obtain the results.The csr confirmed that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.It was also noted by the csr that the patient did not have testing supplies available to test the subject device.The subject products were requested back for investigation and replacements were sent to the patient.This complaint is being reported because whilst using the subject device, the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event.The alleged issue could not be ruled out as a cause or contributor to the onset of symptoms.
Additional Manufacturer Narrative
The lay user/patients meter has 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, lifescan 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.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, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6299232
• Report Number: 3008382007-2017-05564
• Device Sequence Number: 550755
• Product Code: NBW
• UDI-Device Identifier: 00353885001311
• UDI-Public: (01)00353885001311
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 4066273
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2017
• Device Age: 82 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/10/2017
• 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: 77 YR
• Patient Weight: 81