MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL ONE TOUCH LANCING DEVICE; GLUCOSE MONITORING SYS/KIT

Device Problem Defective Component (2292)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

On (b)(6) 2018, a reporter for the lay user/patient contacted lifescan (lfs) usa, alleging an issue with the patient¿s onetouch lancing device.The reporter claimed the lancet holder was damaged.The complaint was classified based on the customer service representative (csr) documentation and on further information obtained when the medical surveillance specialist reviewed the call recording, since the reporter was unable to be reached by phone for additional information.The reporter was unable to confirm when the alleged lancing device issue began.During the call, the reporter claimed the patient had to use the lancets without the lancing device when the lancet holder became damaged.The reporter informed the csr that the patient manages her diabetes with 25 units of levemir insulin twice daily which she was changed to at the beginning of the year and denied the patient made any changes to her usual diabetes management regimen as a result of the alleged issue.The reporter claimed the patient¿s blood glucose went ¿up and down¿ after the alleged issue began and claimed the paramedics had to be contacted for assistance (dates/times not reported).The reporter claimed that on one occasion after the alleged issue started (date/time not reported), the patient¿s ¿tongue got swollen,¿ and she ¿couldn¿t breathe¿.The patient was reportedly taken to hospital where she was treated with banophen 25 mg, famotidine 20 mg and prednisone 50 mg.The reporter claimed the doctor attributed the symptoms to the patient¿s medications (type not reported).During the call, the reporter also claimed the patient¿s blood glucose became ¿very high¿ and was measured on one occasion at over ¿500 mg/dl¿ on an unspecified device.At the time of troubleshooting, the csr noted that the product had been in use for 4 months and that there was no indication of misuse of the device.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly was unable to obtain a blood sample with the subject lancing device and reportedly experienced an acute high blood glucose excursion with a blood glucose result over ¿500 mg/dl¿ after the alleged issue began.The subject lancing device could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

The lay user/patients lancing device has been returned and evaluated by the manufacturer with the following findings: the lancing device involved with this complaint failed testing.The reported issue was confirmed.A re-inspection of the related batches was performed and did not find the same issue.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: ONE TOUCH LANCING DEVICE
• 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: 7555849
• MDR Text Key: 109617498
• Report Number: 3008382007-2018-01567
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

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
• Other Device ID Number: 1-C12HPT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/11/2018
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR
• Patient Weight: 74