MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GN ID TEST KIT

Catalog Number	21341
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer in (b)(6) notified biomérieux of an injury requiring surgery, and claiming that repetitive opening of vitek® 2 gn id test kits (reference 21341) may have contributed to the injury.The customer complained about pain in the thumbs and forearms when opening the vitek 2 card pouches.The customer reports a strong correlation between the new card pouches, and the development of a ganglion in her right hand.The customer reported that the vitek 2 card pouches changed approximately two years ago, and that the new pouches are difficult to open, and cause pain when opened frequently.The customer reported opening approximately fifty (50) vitek 2 card pouches per day.The customer has reported that, six (6) months after the new card pouches were introduced to the customer (the patient), she developed a ganglion in the right hand.The customer reported that the ganglion grew larger and more painful because of the workload - the ganglion was surgically removed in (b)(6) 2019.The customer (patient) reports that she has been working in the same lab for six (6) years, and never had these issues before; after the previous foil pouches of the vitek 2 cards changed, she developed a ganglion which had to be removed surgically.Although this is not evidence that the card pouches are responsible for the customer injury, the customer made the claim that it is a strong possibility.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
A customer in (b)(6) notified biomérieux of an injury requiring surgery, and claiming that repetitive opening of vitek® 2 gn id test kits (reference 21341) may have contributed to the injury.The customer complained about pain in the thumbs and forearms when opening the vitek 2 card pouches.The customer reported a strong correlation between the new card pouches, and the development of a ganglion in her right hand.The customer reported that the vitek 2 card pouches changed approximately two years ago, and that the new pouches are difficult to open, and cause pain when opened frequently.The customer reported opening approximately fifty (50) vitek 2 card pouches per day.The customer has reported that, six (6) months after the new card pouches were introduced to the customer (the patient), she developed a ganglion in the right hand.The customer reported that the ganglion grew larger and more painful because of the workload - the ganglion was surgically removed in (b)(6) 2019.The customer (patient) reports that she has been working in the same lab for six (6) years, and never had these issues before; after the previous foil pouches of the vitek 2 cards changed, she developed a ganglion which had to be removed surgically.Although this is not evidence that the card pouches are responsible for the customer injury, the customer made the claim that it is a strong possibility.Biomérieux internal investigation was conducted.Customers have indicated that some pouches were easier to open than others, and photos of the 'difficult' and 'easier' pouches have been received.- a "difficult" pouch was from ast-p655 lot 8050804103.This pouch was manufactured on manufacturing poucher 4.The pouch has the three-rib side seal and the sawtooth tear notch pattern.The sawtooth pattern provides the user multiple locations to tear the pouch open.This pattern has been used with no modifications since (b)(6) 2016.- an "easier" pouch was from ast-p654 lot 8040935203.This pouch was manufactured on poucher 7.The pouch has the two-rib side seal and a single tear notch.Having fewer ribs means there is less sealed material through which to tear, making the pouch easier to open.In addition to fewer ribs, the tear notch itself changed from a sawtooth pattern to a single tear notch.The sawtooth tear notch design is a zig-zag pattern at the edge of the side seal, whereas the single tear notch design is a notch that is cut into the side seal.The single tear notch essentially starts the tearing process of opening a pouch.To date, poucher 5 and poucher 6 have received the upgrades to the side seal rib count and the tear notch.Validation activities are complete for these pouchers, and they are being used to manufacture distributed lots.Poucher 7, the most recent poucher, has always had the single tear notch and the two-rib side seal.Current projections indicate that validation of pouchers 1 - 4 will be complete by (b)(6) 2019.A customer complaint query was performed for the period (b)(6) 2014 to (b)(6) 2019 for "difficult to open pouches" and/or "injuries related to pouches".The white pouch with the sawtooth tear notch design was implemented in august 2016.The query included two years prior to the white pouch implementation to identify if there were complaints related to difficulty opening pouches with the original silver pouch with a single tear notch design.The report showed no reported complaints related to the silver pouch.In response to four (4) customer complaints regarding difficulty opening white pouches in 2017 and 2018, a decision to move from the sawtooth tear notch design to a single tear notch design was already being implemented prior to receiving the germany complaints in (b)(6) 2019 related to customer injury.This is the reason poucher 7 had the single tear notch design when it was initially installed and then validated in (b)(6) 2018.As no customer complaints relating to difficulty opening pouches and/or injuries from opening pouches had been received for the silver pouch, raw material components were reviewed comparing the silver pouch to the white pouch.The raw material components comparison of the silver pouch to the white pouch show that there were two (2) component changes when the white pouch was approved.However, the overall thickness of the material remained virtually the same.Root cause was determined to be the sawtooth design of the tear notch combined with the 3-rib side seal.Additionally, feedback has been provided by end users stating that the two-rib side seal with a single tear notch design is easier to open compared to the sawtooth tear notch design with the three-rib side seal.The risk associated with difficulty opening vitek 2 pouches is a repetitive stress injury.This is identified in the vitek 2 systems hazard definition and impact document.The upgrades installed to the pouching equipment to implement a single tear notch and a two-rib side seal will make the pouch easier to open.However, the potential for repetitive stress injury still exists and will remain in the vitek 2 systems hazard definition and impact document.The investigation concluded that root cause has been identified, and that mitigating actions are in progress to be completed by october 2019.Note: at the time of this report, only germany has reported events of injury related to the process of opening vitek 2 card pouches.No other countries/customers, even those whose card volume is higher, have reported stress injuries related to the card pouches.

• Brand Name: VITEK® 2 GN ID TEST KIT
• Common Device Name: VITEK® 2 GN ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8639955
• Report Number: 1950204-2019-00153
• Device Sequence Number: 1889351
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: Health Professional
• Device Catalogue Number: 21341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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: Other