MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 3829866

Device Problems Shelf Life Exceeded (1567); High Test Results (2457)

Patient Problems Sweating (2444); Shaking/Tremors (2515)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Lifescan (lfs) has requested return of the subject product(s) for evaluation.If the product(s) are returned, lfs will evaluate it/them and inform fda of product(s) that do not pass inspection in a supplemental report.

Event Description

On (b)(6) 2015, the reporter contacted lifescan (b)(4), alleging that the patient's onetouch verio2 meter read inaccurately high.The following complaint was classified based on information obtained from the customer service representative (csr) documentation.The reporter stated that the alleged product issue began on (b)(6) 2015 at 6:00pm.The reporter stated that the patient obtained a result of "347 mg/dl" using the subject device compared to a result of "63 mg/dl" using another device, both results were taken within 30 minutes apart from each other.Based on statistical methodology, the calculated difference of these glucose results exceeds the expected value of less than or equal to 30%.The patient manages her diabetes with self-adjusting insulin.The reporter stated that the patient took more food/drink on (b)(6) 2015 at 7:00pm in response to the alleged product issue.The reporter claimed that the patient developed the symptoms of "pale skin, shakiness, cold sweat and she was almost unconscious" 30-45 minutes after the alleged product issue began.The reporter stated that the patient self-treated with insulin (dose unknown) on (b)(6) 2015 at 6:30pm.At the time of troubleshooting, the csr noted that the test strips had expired, been open for longer than the discard date or stored improperly, the patient was using the correct testing technique and the patient was using an approved sample site.Replacement products were sent to the patient.Based on the information provided, this complaint is being reported because, the patient developed serious symptoms after the alleged product issue began which do meet lifescan's criteria for a serious injury.

Manufacturer Narrative

Follow-up # 1.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.The retain test strips passed testing.A dhr (device history record) was completed for this product and no deviations, non-conformances, or reworks were observed.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At.

• Brand Name: OT VERIO2 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: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 5152974
• MDR Text Key: 28370609
• Report Number: 2939301-2015-44239
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3829866
• Other Device ID Number: 1-2IZSAO8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2015
• Date Manufacturer Received: 10/13/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention