MAUDE Adverse Event Report: FREESTYLE LANCET; LANCETS

Catalog Number 98682-03

Device Problems Contamination (1120); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/10/2014

Event Type  Injury  

Event Description

A customer, who is a newly diagnosed gestational diabetes patient, reported the following information on behalf of her husband: during a training session, which was attended by both the patient and her husband, the diabetes educator (de) opened the brand new fs freedom lite blood glucose monitoring kit in front of the patient, broke the seals on the box and the seal to the new bag of lancets contained in the kit.The de didn't notice anything unusual and provided the diabetes training.The de was contacted in follow-up and noted that during the training session, she (the de) installed a new lancet, obtained from the just opened bag of lancets, into the lancing device and performed a glucose test on the patient/customer, so the patient/customer could learn the glucose testing process.The lancet used with this practice test was not disposed of at the time of the training session, but left inside the lancing device.The cap for the initial lancet was placed inside the meter case.The system kit contains 10 lancets, in a separately sealed plastic package.Sometime after the session, the customer contacted adc customer service and reported that four (4) of the lancets appeared to have been previously used and then re-capped, as if ready for disposal.The customer contacted the de about the issue on (b)(6), 2014 and stated that she had only used three (3) out of the four (4) lancets.

Manufacturer Narrative

No one else in her family had tampered with photographs showing the 10 lancets; five (5) were unused by the patient and were capped in a manner consistent with a new lancet, and the remaining five (5) were capped in a manner consistent with a used lancet.The patient stated that she had used four (4) lancets of the five (5), and noted that her husband had used one of the lancets, that had been previously used by her.The customer was uncertain which "compromised" lancet was unused and there was concern that she may have used one or more of the potentially "compromised" lancets.The customer again met with the de, on (b)(6), 2014 to reiterate her concerns and informed the de that her husband did indeed use a lancet.It is unknown however, when the husband performed the test on himself or whether he used a new or previously used (by the customer/patient) lancet.Due to her concerns he was referred to his healthcare provider and received testing for (b)(6).These laboratory tests must be repeated at six weeks, three months and six months, post exposure.There was no report of death associated with this event.The customer's products were not returned; however a manufacturing process and document review has determined that the lancets in question were properly capped and sealed in the bag before release.There were no non-conformance reports written for any issues regarding de-capped or damaged lancets in lot w286015.Additionally: the device manufacturer date for the lancet is unknown.A separate mdr 2954323-2014-00862 has been submitted pertaining to the customer/patient.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LANCET
• Type of Device: LANCETS
• MDR Report Key: 4000153
• MDR Text Key: 4779615
• Report Number: 2954323-2014-00863
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 98682-03
• Device Lot Number: W286015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention