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

Lot Number	4142993
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Codes	Fatigue (1849); Blurred Vision (2137); Shaking/Tremors (2515)
Date of Event	06/01/2017
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 a hospital meter (brand not reported).The complaint was classified based on information obtained from the customer service representative (csr) documentation.The patient was unable to recall when the alleged inaccuracy first began.The patient claimed obtaining blood glucose readings of ¿299 mg/dl¿ with the subject meter and ¿199 mg/dl¿ on the other device, performed within 30 minutes of each other.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 manages her diabetes with self-adjusted insulin (humalog) and she advised that in response to the alleged inaccuracy issue, she increased the dose of her insulin based on a sliding scale (dose not specified).The patient reported that an unknown time after the alleged issue occurred, she developed symptoms of feeling ¿fatigue, shakiness and blurred vision¿.The patient stated that she was admitted to hospital in the afternoon of (b)(6) 2017, where she was treated with iv glucose by a health care professional and remained until being discharged on (b)(6) 2017.The patient¿s blood glucose was reportedly measured at ¿199 mg/dl¿ on the hospital device on (b)(6) 2017; however, she was unable to recall the exact time and it was not reported if this result was obtained before or after treatment was administered.At the time of troubleshooting, the csr established that the unit of measure was set correctly on the subject meter, that the patient was following the correct testing procedure 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.The csr walked the patient through a control solution test; however, she was unable and/or unwilling to confirm if the result obtained was within the specified range.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on an allegedly inaccurate high result 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, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6860903
• Report Number: 3008382007-2017-22479
• Device Sequence Number: 11094176
• Product Code: NBW
• UDI-Device Identifier: 00353885002677
• UDI-Public: (01)00353885002677
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 4142993
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/10/2017
• Device Age: 11 MO
• Initial Date Received by Manufacturer: 09/10/2017
• Supplement Date Received by Manufacturer: 09/10/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 49